A Study of Pertuzumab in Participants With Metastatic Breast Cancer

NCT02491892 | Completed Phase 2 Results

• 1 other identifier: BO16934
• Study Type: interventional
• Target: 79
• Locations: 8 countries
• Sites: 18

Brief Summary

This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

  Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

Secondary Outcomes (19)

• Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

• Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

• Percentage of Participants Achieving a Best Overall Response of Confirmed CR

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

• Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

• Number of Participants Who Experienced PD or Death

  Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)

Study Arms (2)

Pertuzumab 1050 mg

EXPERIMENTAL

Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression.

Drug: Pertuzumab

Pertuzumab 420 mg

EXPERIMENTAL

Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.

Drug: Pertuzumab

Interventions

Pertuzumab DRUG

Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.

Also known as: rhuMAb 2C4

Pertuzumab 1050 mg; Pertuzumab 420 mg

Eligibility Criteria

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

You may qualify if:

• Females at least 18 years of age
• Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Karnofsky performance status at least 80%
• Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
• Left ventricular ejection fraction (LVEF) at least 50%
• Adequate liver function

You may not qualify if:

• Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
• Pulmonary or central nervous system (CNS) metastases
• Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
• Previous treatment with any drug that targets the HER2 receptor family
• Previous treatment with corticosteroids as cancer therapy
• History of significant cardiac disease
• Major surgery or trauma within 4 weeks of Day 1
• Pregnant or lactating women

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (18)

Unknown Facility

Camperdown, 2050, Australia

Location

Unknown Facility

Fitzroy, 3065, Australia

Location

Unknown Facility

Geelong, 3220, Australia

Location

Unknown Facility

Namur, 5000, Belgium

Location

Unknown Facility

Helsinki, 00029, Finland

Location

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Tampere, 33520, Finland

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Herne, 44625, Germany

Location

Unknown Facility

München, 81675, Germany

Location

Unknown Facility

Milan, 20133, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Edinburgh, EH4 2XU, United Kingdom

Location

Unknown Facility

London, SE1 9RT, United Kingdom

Location

Unknown Facility

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Recruitment was halted within the planned study design. The study was designed to stop recruitment following the interim analysis if the response rate (CR or PR) was \<1 of 23 participants per arm after all participants completed at least 2 cycles.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: August 25, 2015
• Results First Posted: August 25, 2015

Record last verified: 2015-08

Locations

AU (3); GB (3); ES (3); IT (2); FI (2); NL (1); BE (1); DE (3)