|
Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes Clinical research trials and Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes. Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes  Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes
Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes
For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): Breast International Group , Breast European Adjuvant Studies Team,Austrian Breast Cancer Study Group,Danish Breast Cancer Cooperative Group,Grupo Espanol de Investigacion del Cancer de Mama,Grupo Oncologico Cooperativo Chileno de Investigation,International Breast Cancer Study Group,Irish Clinical Oncology Research Group,Swedish Breast Cancer Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have breast cancer that has spread to the lymph nodes.
Details: OBJECTIVES: I. Compare the disease-free and overall survival of women with node-positive breast cancer treated with adjuvant doxorubicin and docetaxel versus doxorubicin with or without cyclophosphamide, followed by cyclophosphamide, methotrexate, and fluorouracil (CMF). II. Compare the toxic effects of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of axillary lymph nodes ( 1-3 vs 4 or more), and age (under 50 vs 50 and over). Patients are randomized to one of four treatment arms. Arm I: Patients receive doxorubicin (DOX) IV on day 1 every 3 weeks for 4 courses, followed immediately by oral cyclophosphamide (CTX) on days 1-14 and methotrexate IV and fluorouracil IV (CMF) on days 1 and 8 every 4 weeks for 3 courses. Arm II: Patients receive DOX IV and CTX IV on day 1 every 3 weeks for 4 courses, followed immediately by CMF as in arm II. Arm III: Patients receive DOX IV on day 1 every 3 weeks for 3 courses, followed by docetaxel (TXT) IV over 1 hour on day 1 every 3 weeks for 3 courses, followed by CMF as in arm I. Arm IV: Patients receive DOX IV followed 1 hour later by TXT IV over 1 hour on day 1 every 3 weeks for 4 courses, followed by CMF as in arm I. Hormonal therapy: Beginning 4-5 weeks after day 1 of the last course, patients with estrogen and/or progesterone receptor-positive disease receive oral tamoxifen daily for 5 years. Radiotherapy: Beginning 4-6 weeks after day 1 of the last CMF course, patients undergo radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until relapse. PROJECTED ACCRUAL: A total of 2890 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven operable, node-positive breast cancer; T1-3, N0-1, M0 (stage I, IIA, or IIB); Invasive adenocarcinoma with at least 1 positive axillary lymph node upon histologic examination of at least 8 nodes (no supraclavicular nodes); No locally advanced or metastatic disease; No more than 60 days since prior definitive surgery (including axillary node dissection); Definitive surgery must be either mastectomy or breast-conserving surgery - Patients with a positive margin after breast-conserving surgery may be eligible if they undergo adequate resection or mastectomy with clear margins - No prior or concurrent ipsilateral or contralateral invasive adenocarcinoma or contralateral ductal carcinoma in situ; Prior or concurrent ipsilateral ductal in situ or lobular carcinoma in situ allowed - No histologically documented infiltration of the skin (pT4) - Hormone receptor status: Estrogen and/or progesterone receptor status known --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy for breast cancer; No concurrent immunotherapy - Chemotherapy: No prior chemotherapy for breast cancer; No other concurrent chemotherapy - Endocrine therapy: No prior hormonal therapy for breast cancer; No chronic corticosteroid therapy unless initiated more than 6 months prior to study and given at low dose (e.g., no greater than 20 mg methylprednisolone); No concurrent hormone replacement therapy; No other concurrent hormonal therapy - Radiotherapy: No prior radiotherapy for breast cancer; No other concurrent radiotherapy - Surgery: See Disease Characteristics - Other: At least 30 days since other prior clinical trials with investigational drugs; No other concurrent experimental drugs; No other concurrent anticancer therapy; No concurrent amifostine or cardioprotector medications; Concurrent bisphosphonates for nononcologic indications allowed --Patient Characteristics-- - Age: 18 to 70 - Sex: Female - Menopausal status: Not specified - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than upper limit of normal (ULN); SGOT and SGPT no greater than 1.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: LVEF above lower limit of normal by MUGA scan or echocardiogram; No congestive heart failure; No unstable angina pectoris; No myocardial infarction within the past year; No uncontrolled hypertension; No high-risk, uncontrolled arrhythmias - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective nonhormonal contraception; No contraindication for corticosteroids; No significant neurologic or psychiatric disorders (e.g., dementia or seizures) that would preclude compliance; No uncontrolled active infection; No active peptic ulcers; No unstable diabetes mellitus; No prior grade 2 or greater motor or sensory neurotoxicity; No other prior or concurrent malignancy except curatively treated basal cell skin cancer or adequately treated carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinePiccart-Gebhart, Study Chair, Breast International Group
Hospital General - Alicante
Alicante, , 3010
Spain
St. Vincent's Hospital
Dublin, , 4
Ireland
Institut Jules Bordet
Brussels, , 1000
Belgium
Rigshospitalet
Copenhagen, , 2100
Denmark
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
Instituto de Radiomedicina
Santiago, , 10
Chile
Chirurgische Universitaetsklinik
Vienna, , A-1090
Austria
Karolinska Hospital
Stockholm, , S-171 76
Sweden
Additional Information:
Study ID Numbers: CDR0000067653; EU-20002,BIG-2-98,RP-56976-V-315
Study Start Date: March 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005659
Other Stage 1 Breast Cancer Studies:
1. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
2. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
3. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
4. Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
5. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Clinical Trials
Other Stockholm Clinical Trials
Combination Chemotherapy in Treating Patients With Breast Cancer That Has Spread to the Lymph Nodes
|
|
|
|
|
|
|
|
