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Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer that is operable or has spread from where it started to nearby tissue or lymph nodes (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.
Official title: A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2014-02-18
Completion Date
2025-06-30
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Aromatase Inhibition Therapy
Given at the investigator's discretion
Carboplatin
Given IV
Cytology Specimen Collection Procedure
Undergo 2 core biopsies
Docetaxel
Given IV
Goserelin Acetate
Given SC
Laboratory Biomarker Analysis
Correlative studies
Pertuzumab
Given IV
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
Undergo lumpectomy or mastectomy
Trastuzumab
Given IV
Whole Breast Irradiation
Undergo whole breast irradiation
Locations (732)
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
PCR Oncology
Arroyo Grande, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Sutter Davis Hospital
Davis, California, United States
Epic Care-Dublin
Dublin, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Memorial Medical Center
Modesto, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
El Camino Hospital
Mountain View, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Wilma Chan Highland Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Southwest Oncology PC
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States