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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer  Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
For Condition: stage 3A breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): Scottish Cancer Therapy Network ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.
Details: OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer, as measured by overall and event free survival from the date or randomization. II. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by quality of life. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years. PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, early stage, unilateral invasive breast cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node metastases OR Lymph node negative; Not locally advanced; If supraclavicular node is enlarged or suspicious of metastasis, negative biopsy for supraclavicular node metastases required; No evidence of any other metastases clinically or on routine staging investigations - No past history of pure in situ carcinoma in either breast - Primary tumor is completely excised --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Prior tamoxifen allowed - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Not specified - Sex: Female - Performance status: Not specified - Hematopoietic: Neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3; No evidence of sepsis - Hepatic: Adequate hepatic function; Bilirubin normal AST/ALT normal - Renal: Adequate renal function; Creatinine less than 1.2 mg/dL - Cardiovascular: No clinically significant cardiovascular disease - Other: No prior or concurrent other malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisTwelves, Study Chair, Scottish Cancer Therapy Network
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Ayr Hospital
Ayr, , KA6 6DX
United Kingdom
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Royal Alexandra Hospital
Paisley, Scotland,
United Kingdom
Falkirk Royal Infirmary
Falkirk, , FK1 5RE
United Kingdom
University Hospitals of Leicester
Leicester, England, LE1 5WW
United Kingdom
University of Glasgow
Glasgow, Scotland, G61 1BD
United Kingdom
Additional Information:
Study ID Numbers: CDR0000065590; SCTN-BR9601,EU-97013
Study Start Date: October 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003012
Other Stage 3a Breast Cancer Studies:
1. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
2. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
3. Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage II or Stage III Breast Cancer
4. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
5. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Scotland Clinical Trials
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Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
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