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Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer Clinical research trials and Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer. Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer  Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
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 whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without epirubicin in treating women who have early-stage breast cancer and who have undergone surgery to remove the tumor.
Details: OBJECTIVES: - Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin. - Compare the quality of life in a subgroup of these patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses. - Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses. Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment. Patients are followed annually for 10 years. PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histological confirmation of invasive, early stage breast cancer - Prior complete excision of tumor required (wide local excision or mastectomy) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Pre-, peri-, or post-menopausal Performance status: - Not specified Hematopoietic: - Adequate bone marrow function Hepatic: - Adequate hepatic function Renal: - Adequate renal function Other: - No prior cancer except for basal cell carcinoma or carcinoma in situ - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Concurrent hormone therapy allowed Radiotherapy: - No prior radiotherapy - Concurrent radiotherapy allowed Surgery: - See Disease Characteristics - No more than 6 weeks since prior surgery to the breast
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HelenaEarl, Study Chair, University of Cambridge
University of Cambridge *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Helena Earl 44-1223-274-312
Additional Information:
Study ID Numbers: CDR0000066644; CRC-TU-NEAT,EU-98041
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003577
Other Stage 1 Breast Cancer Studies:
1. Tamoxifen in Treating Women With Breast Cancer
2. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
3. Exemestane Compared With Anastrozole, With or Without Celecoxib, in Treating Postmenopausal Women After Surgery for Primary Breast Cancer
4. Lymph Node Radiation Therapy in Patients with Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
5. Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other England Clinical Trials
Other Cambridge Clinical Trials
Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
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