A Study of Pertuzumab in Participants With Metastatic Breast Cancer

NCT ID: NCT02491892

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pertuzumab 1050 mg

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.

Group Type: EXPERIMENTAL

Pertuzumab

Intervention Type: 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.

Pertuzumab 420 mg

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.

Group Type: EXPERIMENTAL

Pertuzumab

Intervention Type: 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.

Interventions

Pertuzumab

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.

Intervention Type: DRUG

Other Intervention Names

rhuMAb 2C4

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Camperdown, , Australia

Fitzroy, , Australia

Geelong, , Australia

Namur, , Belgium

Helsinki, , Finland

Tampere, , Finland

Hamburg, , Germany

Herne, , Germany

München, , Germany

Milan, , Italy

Parma, , Italy

Amsterdam, , Netherlands

Barcelona, , Spain

Barcelona, , Spain

Valencia, , Spain

Edinburgh, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Countries

Australia; Belgium; Finland; Germany; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

BO16934

Identifier Type: -

Identifier Source: org_study_id