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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer Clinical research trials and Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer  Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
For Condition: stage 3A breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group,Cancer and Leukemia Group B,Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.
Details: OBJECTIVES: I. Compare disease free survival and overall survival in women with operable breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide versus standard dose doxorubicin and cyclophosphamide followed by high dose STAMP I (cyclophosphamide, cisplatin, and carmustine) or STAMP V (cyclophosphamide, carboplatin, and thiotepa) and autologous stem cell rescue. II. Compare the toxic effects of these regimens in this patient population. III. Measure the breast cancer cell content of the peripheral blood progenitor cell (PBPC) fractions from patients randomized to the PBPC supported arm and correlate the results with the disease free survival, survival, and pattern of relapse in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, primary treatment (mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy), menopausal status (premenopausal vs postmenopausal), estrogen and/or progesterone receptor status (positive vs negative vs unknown), N2 disease (yes vs no), T3 disease (yes vs no), myeloablative chemotherapy regimen (STAMP I vs STAMP V), and source of progenitor cells (marrow vs peripheral blood vs both). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive doxorubicin IV over 1 hour on days 1, 15, and 29, paclitaxel IV over 24 hours on days 43, 57, and 71, and cyclophosphamide IV over 1 hour on days 85, 99, and 113. Patients receive filgrastim (G-CSF) subcutaneously on days 3-10, 17-24, 31-38, 45-52, 59-66, 73-80, 87-94, 101-108, and 115-122. Arm II: Mobilization chemotherapy: Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1, 22, 43, and 64. Harvest: Patients undergo harvest of autologous bone marrow and/or peripheral blood stem cells (PBSC). Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest. High dose myeloablative chemotherapy: Patients receive STAMP I OR STAMP V: STAMP I: Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3. STAMP V: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Transplantation: Autologous bone marrow and/or PBSC are reinfused on day 0. Both arms: Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years. Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 4.5-5.5 weeks beginning 4-6 weeks after the completion of chemotherapy. Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician. Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven adenocarcinoma of the breast with at least 4 involved axillary and/or intramammary lymph nodes - No known T4, N3, or M1 disease - Dermal lymphatic involvement without clinical inflammatory changes (edema, peau d'orange, erythema) allowed - Must have undergone breast conserving surgery or modified radical mastectomy plus axillary lymph node dissection; Surgical margins negative for invasive or noninvasive ductal carcinoma; At least 10 nodes sampled; No more than 12 weeks since definitive surgery - Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4 weeks of initial histologic diagnosis; One breast meets the eligibility criteria; Other breast has fewer than 10 involved nodes and is not N3 or T4; Both breasts treated by modified radical mastectomy or breast conserving surgery with axillary node dissection - Concurrent registration on S9719 - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: No prior hormonal therapy for breast cancer - Radiotherapy: No prior radiotherapy to the breast - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Adult - Sex: Female - Menopausal status: Any status - Performance status: SWOG 0 or 1 - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 1.5 times ULN; Hepatitis C status required - Renal: Creatinine clearance at least 60 mL/min - Cardiovascular: Left ventricular ejection fraction at rest at least 45% by MUGA; No EKG abnormalities unless cleared by a cardiologist; No uncontrolled or significant cardiac disease; No congestive heart failure; No second or third degree heart block or other serious cardiac conduction abnormality; No atrial or ventricular arrhythmia; No requirement for medication known to affect cardiac conduction unless: Given for reasons other than heart failure or arrhythmia; Cleared by a cardiologist - Pulmonary: FVC and FEV1 at least 60% predicted; DLCO at least 60% predicted - Other: HIV negative; Hepatitis B surface antigen status required; No serious medical or psychiatric illness that would preclude informed consent or study participation; No second malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the breast (diagnosed at any time); Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesColtman, Study Chair, Southwest Oncology Group
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000064747; SWOG-S9623
Study Start Date: July 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002772
Other Stage 3a Breast Cancer Studies:
1. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
2. Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women With Early Breast Cancer
3. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
4. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
5. Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
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