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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00769470 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.
PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: trastuzumab Drug: carboplatin Drug: docetaxel Drug: lapatinib ditosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Multicenter, Open Label, Randomized Phase II Trial of Presurgical Treatment With Single-Agent Trastuzumab (H) or Lapatinib (Ty) or the Combination of Trastuzumab and Lapatinib (H+Ty), Followed by Six Cycles of Docetaxel (T) and Carboplatin (C) With Trastuzumab (TCH) or Lapatinib (TCTy) or the Combination of Trastuzumab and Lapatinib (TCHTy) in Patients With HER2/Neu-Amplified Operable Breast Cancer |
Estimated Enrollment: | 140 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive trastuzumab IV over 90 minutes on day in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV over 30 minutes on day 1 in course 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Biological: trastuzumab
Given IV
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
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Arm II: Experimental
Patients receive oral lapatinib ditosylate once daily on days 1-21 in course 1. Patients receive docetaxel IV and carboplatin IV on day 1 and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7.Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
Drug: lapatinib ditosylate
Given orally
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Arm III: Experimental
Patients receive trastuzumab IV over 90 minutes on day 1 and oral lapatinib ditosylate daily on days 1-21. Starting on day 22, patients receive docetaxel IV, carboplatin IV, and trastuzumab IV three times a week and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Biological: trastuzumab
Given IV
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
Drug: lapatinib ditosylate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to baseline tumor size (≤ 3 cm vs > 3 cm) and hormone receptor status (estrogen receptor [ER]- and/or progesterone receptor [PR]-positive vs ER- and PR- negative). Patients are randomized to 1 of 3 treatment arms.
Within 4-6 weeks after completion of chemotherapy, all patients under go definitive surgery and/or radiotherapy at the discretion of the treating physician. Tumor biopsy and blood samples are collected for biomarker analysis and molecular analysis at baseline, after course 1, and at the time of definitive breast surgery or completion of chemotherapy. Gene expression changes are analyzed by mRNA microarray analysis and molecular changes in protein expression profiles by IHC. Samples may also be analyzed by RT-PCR.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Stage I or II disease (early stage) with tumor measuring ≥ 1 cm and meeting any the following criteria:
Meets none of the following criteria:
PATIENT CHARACTERISTICS:
Alkaline phosphatase (AP), ALT, and AST must meet 1 of the following criteria:
No cardiac disease including any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
Cancer Care Associates Medical Group, Incorporated - Redondo Beach | Recruiting |
Torrance, California, United States, 90505 | |
Contact: David Chan, MD 310-530-9389 | |
Central Coast Medical Oncology Corporation | Recruiting |
Santa Maria, California, United States, 93454 | |
Contact: Robert A. Dichmann, MD 805-349-9393 | |
Central Hematology Oncology Medical Group, Incorporated - Alhambra | Recruiting |
Alhambra, California, United States, 91801 | |
Contact: Eddie H.L. Hu, MD 626-588-2825 | |
Santa Barbara Hematology Oncology - Solvang | Recruiting |
Solvang, California, United States, 93463 | |
Contact: Frederic C. Kass, MD 805-686-5370 | |
North Valley Hematology-Oncology Medical Group | Recruiting |
Northridge, California, United States, 91328 | |
Contact: Sheldon J. Davidson, MD, FACP 818-773-6363 sheljdavid@aol.com | |
Sansum Medical Clinic | Recruiting |
Santa Barbara, California, United States, 93105 | |
Contact: Clinical Trials Office - Sansum Medical Clinic 805-682-7300 | |
Comprehensive Blood and Cancer Center | Recruiting |
Bakersfield, California, United States, 93309-0633 | |
Contact: Clinical Trials Office - Comprehensive Blood and Cancer Center 661-862-7178 | |
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center | Recruiting |
Fullerton, California, United States, 92835 | |
Contact: Giribala Patel, MD 714-446-5900 | |
Wilshire Oncology Medical Group, Incorporated - Pomona | Recruiting |
Pomona, California, United States, 91767-3021 | |
Contact: Linda D. Bosserman, MD, FACP 909-865-9960 linda.bosserman@womgi.com | |
United States, Florida | |
Cancer Institute of Florida, PA - Orlando | Recruiting |
Orlando, Florida, United States, 32804 | |
Contact: Rebecca L. Moroose, MD 407-898-2343 rebecca.moroosemd@flhosp.org | |
Florida Hospital Cancer Institute | Recruiting |
Orlando, Florida, United States, 32804 | |
Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
Hematology and Oncology Consultants, PA - Orlando | Recruiting |
Orlando, Florida, United States, 32804 | |
Contact: Philip H. Dunn, MD 407-898-5452 phdunnmd@att.net | |
United States, Indiana | |
Providence Medical Group | Recruiting |
Haute Terre, Indiana, United States, 47802 | |
Contact: Sang Huh, MD 812-232-1418 thehuh@aol.com | |
United States, Nevada | |
Comprehensive Cancer Centers of Nevada - Henderson | Recruiting |
Henderson, Nevada, United States, 89052 | |
Contact: M. A. Allison, MD 702-952-3444 maryann.allison@usoncology.com | |
United States, New Mexico | |
New Mexico Cancer Center | Recruiting |
Albuquerque, New Mexico, United States, 87109 | |
Contact: Richard O. Giudice, MD 505-842-8171 |
Principal Investigator: | Sara Hurvitz, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000616008, TRIO-TORI-B-07, SANOFI-AVENTIS-TRIO-TORI-B-07, WIRB-20080822 |
Study First Received: | October 8, 2008 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00769470 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer HER2-positive breast cancer |
Docetaxel Skin Diseases Trastuzumab Breast Neoplasms |
Lapatinib Carboplatin Protein Kinase Inhibitors Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors Lapatinib Carboplatin Protein Kinase Inhibitors |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Breast Diseases |