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

NCT ID: NCT01674062

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

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

Study Groups

Pertuzumab + Trastuzumab (Cohorts 1 and 2)

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.

Group Type: EXPERIMENTAL

Pertuzumab

Intervention Type: DRUG

Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.

Trastuzumab

Intervention Type: DRUG

2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.

Pertuzumab +/- Trastuzumab (Cohort 3)

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.

Group Type: EXPERIMENTAL

Pertuzumab

Intervention Type: DRUG

Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.

Trastuzumab

Intervention Type: DRUG

2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.

Interventions

Pertuzumab

Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Trastuzumab

2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Perjeta; Herceptin

Eligibility Criteria

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

• 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

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Besançon, , France

Dijon, , France

Lille, , France

Montpellier, , France

Modena, Emilia-Romagna, Italy

Parma, Emilia-Romagna, Italy

Milan, Lombardy, Italy

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Edinburgh, , United Kingdom

Manchester, , United Kingdom

Northwood, , United Kingdom

Truro, , United Kingdom

Countries

Canada; France; Italy; Spain; United Kingdom

Other Identifiers

2005-003493-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO17929

Identifier Type: -

Identifier Source: org_study_id