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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer  Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
For Condition: stage 3C breast cancer,stage 4 breast cancer,inflammatory breast cancer,stage 2 breast cancer,stage 3A breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): UNC Lineberger Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.
Details: OBJECTIVES: - Determine the cardiac and other toxicity of paclitaxel when administered with trastuzumab (Herceptin) after doxorubicin and cyclophosphamide in women with stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV breast cancer. - Determine whether the addition of paclitaxel with or without trastuzumab to conventional breast cancer adjuvant therapy (doxorubicin and cyclophosphamide) further decreases tumor size and the number of positive axillary nodes in these patients. - Determine the 5-year disease-free survival and overall survival of patients treated with these regimens. - Determine whether the initial pathologic response in patients receiving neoadjuvant therapy correlates with the eventual 5-year disease-free survival or overall survival. - Compare the number of patients eligible for breast-conserving cancer surgery after treatment with doxorubicin and cyclophosphamide vs paclitaxel and trastuzumab. - Correlate clinical and radiographic response rate with pathologic response rate in the primary tumor and axillary lymph nodes and determine which parameter best determines the pathologic response rate in patients treated with these regimens. OUTLINE: Patients are assigned to receive either neoadjuvant therapy (HER-2 overexpressing and nonoverexpressing patients) or adjuvant therapy (HER-2 overexpressing patients only). - Patients assigned to receive neoadjuvant therapy receive one of two treatment regimens. - Regimen I (HER-2 nonoverexpressing patients or HER-2 overexpressing patients who refuse trastuzumab (Herceptin) therapy): Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes and paclitaxel IV over 3 hours on day 1 every 3 weeks for a total of 4 courses. Patients then undergo surgery with or without adjuvant radiotherapy and/or oral tamoxifen. - Regimen II (HER-2 overexpressing patients only): Patients receive doxorubicin and cyclophosphamide as in regimen I. After completion of course 4, patients receive paclitaxel IV and trastuzumab IV over 90-150 minutes weekly on weeks 13-24. Patients then undergo surgery with or without adjuvant radiotherapy. Patients then receive trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy. - Adjuvant therapy: Patients who are assigned to receive adjuvant therapy (HER-2 overexpressing patients only) receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 every 3 weeks for a total of 4 courses. After completion of course 4, patients receive paclitaxel IV and trastuzumab IV over 90 minutes weekly on weeks 13-24. Patients then may undergo radiotherapy followed by trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 125 patients (100 in the neoadjuvant group and 25 in the adjuvant group) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast - Fine needle aspiration, core needle biopsy, or incisional biopsy allowed - No excisional biopsy - Any of the following: - T2, N1 or T3, N0 - Any T with N2 (including axillary lymph nodes matted to one another) or N3 - Any T4, including inflammatory breast cancer - Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor - Supraclavicular or infraclavicular positive lymph nodes without distant metastases - Distant metastases with measurable disease in breast or lymph nodes - Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria - Measurable or evaluable disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 9 g/dL Hepatic: - Bilirubin less than 1.5 times normal Renal: - Creatinine less than 1.5 times normal Cardiovascular: - LVEF normal by resting nuclear ventriculogram Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior malignancies except: - Effectively treated squamous cell or basal cell skin cancer - Carcinoma in situ of the cervix that has been curatively treated by surgery alone - Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LisaCarey, Study Chair, UNC Lineberger Comprehensive Cancer Center
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Gretchen Kimmick 336-716-0230
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7305
United States
Recruiting Lisa Carey 919-966-4431
Additional Information:
Study ID Numbers: CDR0000068121; UNC-9818,NCI-G00-1836
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006110
Other Stage 3c Breast Cancer Studies:
1. Biological Therapy in Treating Patients With Advanced Cancer
2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
3. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
4. Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer
5. Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
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