Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

NCT05155566 | Completed Results

• 2 other identifiers: A5481125IRIS LATAM
• Study Type: observational
• Target: 847
• Locations: 2 countries
• Sites: 2

Brief Summary

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.

Conditions

Breast Cancer Metastatic

Keywords

human epidermal growth factor receptor 2 negative (HER2-); hormone receptor positive (HR+); advanced breast cancer (ABC); metastatic breast cancer (MBC)

Outcome Measures

Primary Outcomes (24)

• Progression Free Rate at Month 6

  Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

  Month 6 (from the data collected and observed retrospectively for approximately 22 months)

• Progression Free Rate at Month 12

  Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

  Month 12 (from the data collected and observed retrospectively for approximately 22 months)

• Progression Free Rate at Month 18

  Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

  Month 18 (from the data collected and observed retrospectively for approximately 22 months)

• Progression Free Rate at Month 24

  Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.

  Month 24 (from the data collected and observed retrospectively for approximately 22 months)

• Objective Response Rate

  Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

  From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation

  Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.

  1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)

• Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation

  Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.

  2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)

• Clinical Benefit Rate

  Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.

  From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib

  SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.

  From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Survival Rate at Month 6

  Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.

  Month 6 (from the data collected and observed retrospectively for approximately 22 months)

• Survival Rate at Month 12

  Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.

  Month 12 (from the data collected and observed retrospectively for approximately 22 months)

• Survival Rate at Month 18

  Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.

  Month 18 (from the data collected and observed retrospectively for approximately 22 months)

• Survival Rate at Month 24

  Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.

  Month 24 (from the data collected and observed retrospectively for approximately 22 months)

• Time From Palbociclib Initiation to Initial Response Recorded

  CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.

  From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Time From Palbociclib Initiation to Complete Response

  CR was defined as complete resolution of all visible disease per the treating physicians opinion.

  From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Time From Palbociclib Initiation to Partial Response

  PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

  From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Follow-up Time Since Palbociclib Initiation

  From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Number of Participants With Supportive Therapies

  Number of participants who received supportive therapies during palbociclib treatment were reported.

  From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Duration of Ongoing Palbociclib Treatment

  Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Duration of Discontinued Palbociclib Treatment

  Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Number of Participants According to Therapies Received Post Palbociclib Treatment

  Number of participants who received therapies post palbociclib treatment were reported.

  Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Time From Palbociclib Initiation to First Dose Reduction

  Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Duration of Dose Interruption

  Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

• Duration of Cycle Delays

  Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

Study Arms (1)

Breast Cancer Patients

HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective medical data review of patients who have received palbociclib combination treatments as first line treatment regardless of combination partner and labelled use in Argentina, Chile, Peru, Mexico and a combined sample in Costa Rica and Panama.

You may qualify if:

• Oncologist or gynecologist.
• Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
• Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.
• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
• Received palbociclib as a first line therapy.
• No prior or current enrolment in an interventional clinical trial for ABC/MBC.
• Minimum of six months of follow up data since palbociclib initiation.

You may not qualify if:

• Qualified less than 2 years ago or more than 35 years ago.
• Participated in observational research for ABC/MBC in the last 3 months.
• Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer country office

Buenos Aires, Argentina

Location

Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK

Bollington, Chesshire, SK105JB, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 13, 2021
• Study Start: May 15, 2019
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: January 26, 2024
• Results First Posted: January 26, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); AR (1)