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Home > "D" Clinical Trials Conditions > Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer  Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
For Condition: stage 2 breast cancer,stage 3A breast cancer,stage 3B breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combining docetaxel and carboplatin with or without trastuzumab before surgery in treating women who have locally advanced breast cancer.
Details: OBJECTIVES: - Compare the objective response rate of women with locally advanced breast cancer treated with neoadjuvant docetaxel and carboplatin with vs without trastuzumab (Herceptin®). - Compare the toxic effects of these regimens in these patients. - Compare disease-free and overall survival in patients treated with these regimens. - Determine the molecular characteristics of tumors that are responsible for drug susceptibility and drug interactions in patients treated with these regimens. - Provide additional prognostic information about these patients for conventional pathology studies. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, initial tumor size, tumor type (T3 vs T4), presence of clinically positive lymph nodes (yes vs no), and mother's family history (positive vs negative). - All patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 or 2. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who are HER2/neu positive are randomized to 1 of 2 concurrent trastuzumab (Herceptin®) treatment arms. - Arm I: Patients receive trastuzumab (concurrently with chemotherapy) IV over 30-90 minutes on days 1, 8, and 15. Trastuzumab repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients do not receive concurrent trastuzumab. Patients receive neoadjuvant chemotherapy only. - Surgery: Within 3 weeks after completion of course 4 of neoadjuvant therapy, patients with responding disease undergo definitive surgery. - Adjuvant therapy: Within 4-6 weeks after surgery, patients with responding disease receive 4 additional courses of docetaxel and carboplatin as during neoadjuvant chemotherapy. All HER2/neu positive patients also receive trastuzumab IV once weekly for 12 weeks and then every 3 weeks for 40 weeks (total of 52 weeks of trastuzumab therapy). Within 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy. Estrogen-receptor positive patients receive oral tamoxifen once daily for 5 years. Patients are followed annually for 5 years. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed infiltrating adenocarcinoma of the breast - Primary disease greater than 5 cm (T3) OR skin and chest wall involvement (T4) - Any N - No evidence of metastasis (M0) - Diagnosed within the past 3 months - HER2/neu status determined by fluorescent in situ hybridization - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 80 Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - At least 1 year Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Liver function tests no greater than upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - LVEF normal by MUGA or echocardiogram Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergy to polysorbate or castor oil - No ongoing active infection - No concurrent life-limiting disease - No other malignancy within the past 5 years that could affect the diagnosis or assessment of breast cancer, except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No grade 2 or greater pre-existing peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior trastuzumab (Herceptin®) - No other concurrent immunotherapy - No concurrent gene therapy Chemotherapy - No prior docetaxel - No prior carboplatin - No other concurrent chemotherapy Endocrine therapy - No concurrent antitumor hormonal therapy Radiotherapy - No prior radiotherapy to the involved breast - No concurrent radiotherapy to an indicator lesion Surgery - Not specified Other - More than 5 years since any prior drug therapy for breast cancer - No other concurrent experimental drugs - No other concurrent anticancer treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HelenaChang, Principal Investigator, Jonsson Comprehensive Cancer Center
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting V. Klimberg 501-686-6504
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Christy Russell 323-865-3903
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-7028
United States
Recruiting Helena Chang 310-794-5640
Wilshire Oncology Medical Group, Inc. - Pomona *Recruiting*
Pomona, California, 91767-3021
United States
Recruiting Linda Bosserman 909-865-9960
Additional Information:
Study ID Numbers: CDR0000321924; UCLA-9911084,AVENTIS-GIA-11156,GENENTECH-H2269s
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068341
Other Stage 3c Breast Cancer Studies:
1. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
2. Vaccine Therapy in Treating Patients With Breast Cancer
3. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer
4. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
5. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy
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Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
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