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A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of South Alabama; Mitchell Cancer Institute
Mobile, Alabama, United States
Marin Specialty Care
Greenbrae, California, United States
California Pacific Medical Center
San Francisco, California, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington D.C., District of Columbia, United States
Washington Cancer Institute at MedStar Washington Hospital Center.
Washington D.C., District of Columbia, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Saint Lukes Hospital Cancer Institute
Kansas City, Missouri, United States
Start Date
July 14, 2014
Primary Completion Date
March 3, 2016
Completion Date
August 25, 2020
Last Updated
September 17, 2021
401
ACTUAL participants
5-Fluorouracil
DRUG
Cyclophosphamide
DRUG
Docetaxel
DRUG
Doxorubicin
DRUG
Epirubicin
DRUG
Paclitaxel
DRUG
Pertuzumab
DRUG
Trastuzumab
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05372640
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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