A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab; Drug: Pertuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01674062

BO17929

2005-003493-19 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.

Enrollment: 95 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females greater than or equal to (≥) 18 years of age, with histologically-confirmed HER2-positive breast cancer
• Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease
• Less than or equal to (≤) 3 chemotherapy regimens prior to study entry
• Last trastuzumab dose ≤9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and ≥4 weeks for participants receiving pertuzumab monotherapy
• Left ventricular ejection fraction ≥55% at study entry

Exclusion criteria

• Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab
• Brain metastases
• History of any cardiac adverse event related to trastuzumab therapy
• Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Pertuzumab + Trastuzumab (Cohorts 1 and 2)

Experimental group

Description:

Females with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer will receive dual-agent treatment with pertuzumab and trastuzumab. Trastuzumab will be administered IV as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab will be administered IV at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications will be administered on Day 1 of each 3-week cycle. Treatment will continue for a minimum of 8 cycles and may be extended until disease progression, intolerable toxicity, or death.

Treatment:

Drug: Pertuzumab

Drug: Trastuzumab

Pertuzumab +/- Trastuzumab (Cohort 3)

Experimental group

Description:

Females with HER2-positive metastatic breast cancer will receive single-agent treatment with pertuzumab. Pertuzumab will be administered IV at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression may have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.

Treatment:

Drug: Pertuzumab

Drug: Trastuzumab