A Study of Pertuzumab in Participants With Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02491892

BO16934

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Pertuzumab 1050 mg

Experimental group

Description:

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.

Treatment:

Drug: Pertuzumab

Pertuzumab 420 mg

Experimental group

Description:

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.

Treatment:

Drug: Pertuzumab