A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

NCT01572038 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MO280472011-005334-20
• Study Type: interventional
• Target: 1,436
• Locations: 36 countries
• Sites: 285

Brief Summary

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (27)

• Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)

  All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal

  The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)

  All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal

  The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab

  Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

  From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With a Congestive Heart Failure Event

  Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).

  From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Time to Onset of the First Episode of Congestive Heart Failure

  Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.

  From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study

  All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.

  Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study

  All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (\<)10% points or no change in LVEF; 2) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥10% points to \<15% points; 3) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥15% points; or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline; Decr. = decrease; Incr. = increase

  Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0

  Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.

  Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria

  Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.

  Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0

  Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.

  Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

• Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria

  Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.

  Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

Secondary Outcomes (31)

• Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

  From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1

  From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1

  From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1

  From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

• Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1

  From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.

Study Arms (1)

Pertuzumab + Trastuzumab + Taxane

EXPERIMENTAL

Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.

Drug: Docetaxel; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Pertuzumab; Drug: Trastuzumab

Interventions

Docetaxel DRUG

Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Pertuzumab + Trastuzumab + Taxane

Nab-paclitaxel DRUG

Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Pertuzumab + Trastuzumab + Taxane

Paclitaxel DRUG

Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Pertuzumab + Trastuzumab + Taxane

Pertuzumab DRUG

Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.

Also known as: RO 43-68451

Pertuzumab + Trastuzumab + Taxane

Trastuzumab DRUG

Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.

Also known as: Herceptin

Pertuzumab + Trastuzumab + Taxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
• HER2-positive breast cancer
• Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• LVEF of at least 50 percent (%)

You may not qualify if:

• Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
• Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months
• Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
• Central nervous system (CNS) metastases
• Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
• History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
• Inadequate bone marrow, liver or renal function
• Uncontrolled hypertension
• Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (299)

CPMC; Service d'Oncologie Médicale

Algiers, 16000, Algeria

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

Instituto de Oncología de Rosario

Rosario, S2000KZE, Argentina

Location

Canberra Hospital; Medical Oncology

Canberra, Australian Capital Territory, 2606, Australia

Location

Royal Prince Alfred Hospital; Medical Oncology

Camperdown, New South Wales, 2050, Australia

Location

HOCA Chermside

Chermside, Queensland, 4032, Australia

Location

Mater Hospital; Cancer Services

South Brisbane, Queensland, 4101, Australia

Location

Austin and Repatriation Medical Centre; Cancer Services

Melbourne, Victoria, 3084, Australia

Location

Royal Melbourne Hospital; Hematology and Medical Oncology

Parkville, Victoria, 3052, Australia

Location

Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

Graz, 8036, Austria

Location

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

Graz, 8036, Austria

Location

Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

Innsbruck, 6020, Austria

Location

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

Linz, 4010, Austria

Location

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, 5020, Austria

Location

A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

Steyr, 4400, Austria

Location

Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

Vienna, 1090, Austria

Location

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

Vienna, 1090, Austria

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

Oncologistas Associados

Rio de Janeiro, Rio de Janeiro, 22271-110, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

Hospital Sirio Libanes; Centro de Oncologia

São Paulo, São Paulo, 01308-050, Brazil

Location

Hospital Perola Byington

São Paulo, São Paulo, 01317-000, Brazil

Location

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Hospital Sao Jose

São Paulo, São Paulo, CEP 01321-001, Brazil

Location

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, T6G 1Z2, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Bcca - Vancouver Island Cancer Centre; Oncology

Victoria, British Columbia, V8R 6V5, Canada

Location

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

William Osler Health System Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CSSS champlain - Charles-Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C2, Canada

Location

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, H3T 1E2, Canada

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Southwest Hospital , Third Military Medical University

Chongqing, 400038, China

Location

Sun Yet-sen University Cancer Center

Guangzhou, 510060, China

Location

Heilongjiang Provincial Tumor Hospital

Harbin, 150040, China

Location

Jiangsu Cancer Hospital

Nanjing, 210009, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

Xi'an, 710032, China

Location

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, 710061, China

Location

Hospital Solca Portoviejo; Oncologia

Portoviejo, EC130104, Ecuador

Location

Hospital Solca Quito; Oncologia

Quito, EC170124, Ecuador

Location

Manial Specialized Hospital; Oncology

Cairo, 11555, Egypt

Location

El Mokatam HIO Hospital

Cairo, 11654, Egypt

Location

Nci; Oncology Dept

Cairo, 11796, Egypt

Location

North Estonia Medical Centre Foundation; Oncology Center

Tallinn, 13419, Estonia

Location

Tartu University Hospital; Clinic of Hematology and Oncology

Tartu, 50406, Estonia

Location

Helsinki University Central Hospital; Oncology Clinics

Helsinki, 00029, Finland

Location

Satakunta Central Hospital; Oncology

Pori, 28500, Finland

Location

Tampere University Hospital; Dept of Oncology

Tampere, 33520, Finland

Location

Turku Uni Central Hospital; Oncology Clinics

Turku, 20520, Finland

Location

Clinique De L Europe; Radiotherapie Chimiotherapie

Amiens, 80090, France

Location

ICO Paul Papin; Oncologie Medicale.

Angers, 49055, France

Location

Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

Bordeaux, 33077, France

Location

Centre Hospitalier Fleyriat; Oncologie/Hematologie

Bourg-en-Bresse, 01012, France

Location

Centre Leonard De Vinci;Chimiotherapie

Dechy, 59187, France

Location

Fondation Clement Drevon; Oncology

Dijon, 21000, France

Location

Centre Georges Francois Leclerc; Oncologie 3

Dijon, 21079, France

Location

Clinique Sainte Marguerite; Oncologie Medicale

Hyères, 83400, France

Location

Polyclinique de Blois; Chimiotherapie Ambulatoire

La Chaussée-Saint-Victor, 41260, France

Location

Clinique Victor Hugo

LeMans, 72000, France

Location

Polyclinique Du Bois; Centre Bourgogne

Lille, 59000, France

Location

Clinique Chenieux; Oncology

Limoges, 87039, France

Location

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Location

Institut Paoli Calmettes; Oncologie Medicale

Marseille, 13273, France

Location

Centre Azureen De Cancerologie; Cons externes

Mougins, 06250, France

Location

Hopital Cochin; Unite Fonctionnelle D Oncologie

Paris, 75014, France

Location

Hopital Hotel Dieu; Oncologie Medicale

Paris, 75181, France

Location

Institut Curie; Oncologie Medicale

Paris, 75231, France

Location

Hopital Saint Louis; Service Onco Thoracique

Paris, 75475, France

Location

Centre Catalan D' Oncologie

Perpignan, 66000, France

Location

Polyclinique De Courlancy; Centre Radiotherapie Oncologie

Reims, 51057, France

Location

Centre Eugene Marquis; Unite Huguenin

Rennes, 35042, France

Location

Centre Rene Huguenin; ONCOLOGIE GENETIQUE

Saint-Cloud, 92210, France

Location

Chp Saint Gregoire; Cancerologie Radiotherapie

Saint-Grégoire, 35768, France

Location

Ico Rene Gauducheau; Oncologie

Saint-Herblain, 44805, France

Location

Institut D Oncologie Medical

Strasbourg, 67000, France

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

Hopital Prive Drome Ardeche; Hopital De Jour

Valence, 26000, France

Location

Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

Valenciennes, 59300, France

Location

Klinikum am Bruderwald; Frauenklinik

Bamberg, 96049, Germany

Location

Gynaekologicum Bremen; Prof. Dr. Willibald Schröder

Bremen, 28211, Germany

Location

Universitätsklinikum Erlangen; Frauenklinik

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, 45122, Germany

Location

Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

Esslingen am Neckar, 73730, Germany

Location

AGAPLESION Markus-Krankenhaus

Frankfurt, 60431, Germany

Location

SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe

Gera, 07548, Germany

Location

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

Hamburg, 20246, Germany

Location

Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

Hanover, 30177, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

Homburg/Saar, 66424, Germany

Location

St.-Vincenz-Krankenhaus; Frauenklinik

Limburg, 65549, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

Lübeck, 23538, Germany

Location

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

Mönchengladbach, 41061, Germany

Location

Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

München, 81675, Germany

Location

Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

Neuruppin, 16816, Germany

Location

Agaplesion Diakonieklinikum Rotenburg

Rotenburg (Wümme), 27356, Germany

Location

Praxis Dr. Wagner

Saarbrücken, 66113, Germany

Location

Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

Torgau, 04860, Germany

Location

Universitätsklinik Tübingen; Frauenklinik

Tübingen, 72076, Germany

Location

Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

Athens, 115 22, Greece

Location

Hippokratio Hospital; 2Nd Internal Medicine

Athens, 115 27, Greece

Location

University General Hospital of Heraklion

Crete, 711 10, Greece

Location

University Hospital of Larissa; Oncology

Larissa, 413 35, Greece

Location

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Location

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546 45, Greece

Location

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, 564 29, Greece

Location

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, Hong Kong

Location

Szent Margit Hospital; Dept. of Oncology

Budapest, 1032, Hungary

Location

Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

Budapest, 1097, Hungary

Location

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

Debrecen, 4032, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

Miskolc, 3501, Hungary

Location

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

Szeged, 6720, Hungary

Location

Soroka Medical Center; Oncology Dept

Beersheba, 8410100, Israel

Location

Rambam Medical Center; Oncology

Haifa, 3109601, Israel

Location

Wolfson Hospital; Oncology

Holon, 5822012, Israel

Location

Shaare Zedek Medical Center; Oncology Dept

Jerusalem, 9103102, Israel

Location

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112000, Israel

Location

Nahariya Hospital; Oncology

Nahariya, 22100, Israel

Location

Rabin Medical Center; Oncology Dept

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, 5262100, Israel

Location

Kaplan Medical Center; Oncology Inst.

Rehovot, 7610001, Israel

Location

Sourasky / Ichilov Hospital; Dept. of Oncology

Tel Aviv, 6423906, Israel

Location

Assuta Medical Centre; Oncology

Tel Aviv, Israel

Location

Assaf Harofeh; Oncology

Ẕerifin, 6093000, Israel

Location

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Campania, 83100, Italy

Location

Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

Piacenza, Emilia-Romagna, 29100, Italy

Location

Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

Ravenna, Emilia-Romagna, 48100, Italy

Location

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Ospedale Belcolle Di Viterbo; Oncologia

Viterbo, Lazio, 01100, Italy

Location

Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

Genoa, Liguria, 16128, Italy

Location

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, 24127, Italy

Location

Ospedale Mater Salutis; Dept of Oncology

Legnago, Lombardy, 37045, Italy

Location

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, 20132, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.

Pavia, Lombardy, 27100, Italy

Location

Ospedale Maggiore Della Carita; Oncologia Medica

Novara, Piedmont, 28100, Italy

Location

Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

Ponderano (BI), Piedmont, 13875, Italy

Location

Fondazione Del Piemonte; Medical Oncology

Turin, Piedmont, 70060, Italy

Location

Ospedale S. Vincenzo; Oncologia Medica

Taormina, Sicily, 98030, Italy

Location

Ospedali Riuniti Di Ancona; Oncology

Ancona, The Marches, 60121, Italy

Location

Ospedale Di Macerata; Oncologia

Macerata, The Marches, 62100, Italy

Location

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, 50139, Italy

Location

Arcispedale S.Anna; Oncologia Medica

Cona (Ferrara), Veneto, 44124, Italy

Location

American University of Beirut - Medical Center

Beirut, 1107 2020, Lebanon

Location

Hotel Dieu de France; Oncology

Beirut, 2063 1111, Lebanon

Location

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Uni Oncology Inst. ; Chemo - Radiation Dept

Vilnius, 08660, Lithuania

Location

Iem-Fucam

D.F., 04980, Mexico

Location

Medica Sur Centro Oncologico Integral

D.F., 14050, Mexico

Location

Instituto Nacional de Cancerologia; Oncology

Distrito Federal, 14080, Mexico

Location

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

Mexico City, 03100, Mexico

Location

Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia

Mexico City, 06720, Mexico

Location

Hospital General de México; Unidad de Oncologia

Mexico City, 06726, Mexico

Location

Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

Mexico City, Tlalpan 14000, Mexico

Location

Cancerologia de Queretaro; Oncologia

Queretaro, Queretaro, 76090, Mexico

Location

Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

Rabat, 10000, Morocco

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT, Netherlands

Location

Catharina ZKHS; Inwendige Geneeskunde Afd.

Eindhoven, 5623 EJ, Netherlands

Location

Martini Ziekenhuis; Dept of Internal Medicine

Groningen, 9728 NT, Netherlands

Location

Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

Leidschendam, 2262 BA, Netherlands

Location

Ikazia Ziekenhuis; Interne Oncologie

Rotterdam, 3083 AN, Netherlands

Location

Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

Tilburg, 5042 AD, Netherlands

Location

Vie Curie

Venlo, 5912 BL, Netherlands

Location

Shifa International Hospital; Department of Oncology

Islamabad, 44000, Pakistan

Location

Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

Lahore, 54000, Pakistan

Location

Hameed Latif Hospital; Department of Oncology

Lahore, 54600, Pakistan

Location

Instituto;Oncologico Miraflores

Lima, 18, Peru

Location

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Lima, Lima 41, Peru

Location

Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

Lima, Lima11, Peru

Location

Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

Bialystok, 15-027, Poland

Location

Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

Kielce, 25-734, Poland

Location

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

Lodz, 93-513, Poland

Location

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

Otwock, 05-400, Poland

Location

Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

Warsaw, 02-781, Poland

Location

IPO de Coimbra; Servico de Oncologia Medica

Coimbra, 3000-075, Portugal

Location

Hospital do Espirito Santo; Servico de Oncologia Medica

Evora, 7000-811, Portugal

Location

Centro Clinico Champalimaud; Oncologia Medica

Lisbon, 1400-038, Portugal

Location

Hospital da Luz; Departamento de Oncologia Medica

Lisbon, 1500-650, Portugal

Location

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, 1649-035, Portugal

Location

Hospital Beatriz Angelo; Departamento de Oncologia

Loures, 2674-514, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Hospital de Sao Joao; Servico de Oncologia

Porto, 4200-319, Portugal

Location

King Faisal Specialist Hospital & Research Centre; Oncology

Riyadh, 11211, Saudi Arabia

Location

King Abdul Aziz Medical City, King Fahd National Guard; Oncology

Riyadh, 22490, Saudi Arabia

Location

Institute for Onc/Rad Serbia

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Hospital Virgen de los Lirios; Servicio de Oncologia

Alcoy, Alicante, 03804, Spain

Location

Hospital General de Elda; Servicio de Oncologia

Elda, Alicante, 03600, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Jerez de la Frontera; Servicio de Oncologia

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon, Castellon, 12002, Spain

Location

Hospital de Barbastro; Servicio de Oncologia

Barbastro, Huesca, 22300, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia

Logroño, La Rioja, 26006, Spain

Location

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35020, Spain

Location

Fundacion Hospital de Alcorcon; Servicio de Oncologia

Alcorcón, Madrid, 28922, Spain

Location

Hospital Severo Ochoa; Servicio de Oncologia

Leganés, Madrid, 28911, Spain

Location

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, 31008, Spain

Location

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Hospital de Cabueñes; Servicio de Oncologia

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

Reus, Tarragona, 43204, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital de Sagunto; Servicio de Oncologia

Sagunto, Valencia, 46520, Spain

Location

Hospital de Basurto; Servicio de Oncologia

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Quiron Barcelona; Servicio de Oncologia

Barcelona, 08024, Spain

Location

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, 08041, Spain

Location

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

Burgos, 09006, Spain

Location

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, 10003, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

Girona, 17007, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

Granada, 18014, Spain

Location

Hospital General Universitario de Guadalajara; Servicio de Oncologia

Guadalajara, 19002, Spain

Location

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, 24071, Spain

Location

Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

Madrid, 28033, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Fundacion Jimenez Diaz; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, 28050, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, 29010, Spain

Location

Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

Murcia, 30008, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, 30120, Spain

Location

Complejo Hospitalario de Orense; Servicio de Oncologia

Ourense, 32005, Spain

Location

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, 41009, Spain

Location

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, 46015, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

Valladolid, 47005, Spain

Location

Hospital de Rio Hortega; Servicio de Oncologia

Valladolid, 47010, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, 50009, Spain

Location

Gävle Sjukhus; Onkologiska Kliniken

Gävle, 80187, Sweden

Location

Sahlgrenska Universitetssjukhuset; Jubileumskliniken

Gothenburg, 413 45, Sweden

Location

Centralsjukhuset Karlstad, Onkologkliniken

Karlstad, 65185, Sweden

Location

Skånes University Hospital, Skånes Department of Onclology

Lund, 221 85, Sweden

Location

Centrallasarettet Växjö, Onkologkliniken

Vaxjo, 35185, Sweden

Location

Västmanlands sjukhus Västerås, Onkologkliniken

Västerås, 72189, Sweden

Location

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, 01250, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, 07070, Turkey (Türkiye)

Location

Ege University Medical Faculty; Medical Oncology Department

Bornova, İ̇zmi̇r, 35100, Turkey (Türkiye)

Location

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Location

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

Dnipropetrovsk, 49102, Ukraine

Location

Kyiv City Clinical Oncological Center; Chemotherapy Department

Kiev, 03115, Ukraine

Location

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

Lviv, 79031, Ukraine

Location

Zaporozhye Regional Oncology Hospital; Dept of Oncology

Zaporizhzhya, 69104, Ukraine

Location

Tawam Hospital

Al Ain City, 15258, United Arab Emirates

Location

Royal United Hospital; Oncology Department

Bath, BA1 3NG, United Kingdom

Location

City Hospital NHS Trust

Birmingham, B18 7QH, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Addenbrookes Hospital; Dept of Oncology

Cambridge, CB2 2QQ, United Kingdom

Location

Velindre Hospital

Cardiff, CF14 2TL, United Kingdom

Location

Walsgrave Hospital

Coventry, CV2 2DX, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

University Hospital of North Durham

Durham, DH15TW, United Kingdom

Location

Hairmyres Hospital; Oncology Dept

East Kilbride, G75 8RG, United Kingdom

Location

Eastbourne District Hospital; Department of Pharmacy

Eastbourne, BN21 2UD, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Diana Princess of Wales Hosp.

Grimsby, DN33 2BA, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

Leeds, LS9 7TF, United Kingdom

Location

Huddersfield Royal Infirmary - Pharmacy department

Lindley, HD3 3EA, United Kingdom

Location

Barts and the London NHS Trust.

London, EC1A 7BE, United Kingdom

Location

Royal Free Hospital; Dept of Oncology

London, NW3 2QG, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Royal Marsden Hospital - London

London, SW3 6JJ, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, SK10 3BL, United Kingdom

Location

Christie Hospital; Breast Cancer Research Office

Manchester, M20 4QL, United Kingdom

Location

James Cook Uni Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Freeman Hospital; Northern Centre For Cancer Care

New Castle Upon Tyne, NE7 7DN, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Derriford Hospital; Plymouth Oncology Centre

Plymouth, PL6 8DH, United Kingdom

Location

Musgrove Park Hospital

Somerset, TA1 5DA, United Kingdom

Location

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

Wishaw General Hospital

Wishaw, ML2 0DP, United Kingdom

Location

Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

Montevideo, 11400, Uruguay

Location

Hospital Central De Las FF.AA.; Servicio De Oncologia

Montevideo, 11600, Uruguay

Location

Hospital Pereira Rossell; Oncology Department

Montevideo, 11600, Uruguay

Location

Centro Integral de Oncología

Caracas, 1060, Venezuela

Location

Centro Médico Docente La Trinidad; Servicio de Gastroenterología

Caracas, 1080, Venezuela

Location

Related Publications (1)

• Bachelot T, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Bondarenko I, Paluch-Shimon S, Wardley A, Merot JL, du Toit Y, Easton V, Lindegger N, Miles D; PERUSE investigators. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol. 2019 May 1;30(5):766-773. doi: 10.1093/annonc/mdz061.

  PMID: 30796821 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; 130-nm albumin-bound paclitaxel; Paclitaxel; pertuzumab; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: June 1, 2012
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-08

Locations

SE (2); AE (1); IL (12); UR (3); PE (3); VE (2); UA (4); PT (8); EG (3); MO (1); IT (19); HK (1); LI (2); NL (8); ES (48); ME (8); CA (10); GR (7); FI (4); HU (6); PL (6); DE (20); AR (2); EC (2); FR (29); SL (1); AU (8); CN (9); LE (2); SA (2); TU (5); BE (5); AL (1); PA (3); GB (31); BR (7)