Spots Global Cancer Trial Database for A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
Official Title: An Exploratory Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Pertuzumab and Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer
Study ID: NCT01674062
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, Edmonton, Alberta, Canada
, Vancouver, British Columbia, Canada
, London, Ontario, Canada
, Ottawa, Ontario, Canada
, Toronto, Ontario, Canada
, Besancon, , France
, Dijon, , France
, Lille, , France
, Montpellier, , France
, Modena, Emilia-Romagna, Italy
, Parma, Emilia-Romagna, Italy
, Milano, Lombardia, Italy
, Barcelona, , Spain
, Barcelona, , Spain
, Valencia, , Spain
, Valencia, , Spain
, Edinburgh, , United Kingdom
, Manchester, , United Kingdom
, Northwood, , United Kingdom
, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_CHAIR
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