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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Breast Cancer  Combination Chemotherapy in Treating Women With Breast Cancer
Combination Chemotherapy in Treating Women With Breast Cancer
For Condition: stage 3B breast cancer,stage 3A breast cancer,inflammatory 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. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus cyclophosphamide for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated, advanced, or inflammatory breast cancer.
Details: OBJECTIVES: I. Compare the efficacy (response rate) and toxicity of doxorubicin in combination with either docetaxel or cyclophosphamide as primary therapy regimens in patients with locally advanced or inflammatory breast cancer. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and operability. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV followed by doxorubicin IV once every 3 weeks. Arm II: Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks. Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients then undergo surgery (if operable) followed by more chemotherapy (if node positive), radiation therapy, and oral tamoxifen for 5 years (at the discretion of the investigator for estrogen receptor-negative patients). Patients are followed at 12, 18, and 24 months, and then annually for at least 5 years. PROJECTED ACCRUAL: A total of 350 patients (175 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven previously untreated locally advanced or inflammatory breast cancer - Potentially operable disease - Tumor at least 3 cm in diameter - No metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics - Other: No prior therapy for breast cancer --Patient Characteristics-- - Age: 18 to 60 - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: PT and aPTT normal; Bilirubin normal (except in patients with benign congenital hyperbilirubinemia); AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 1.5 times ULN; No active hepatitis B or C; Liver biopsy normal (if positive serology for hepatitis B or C) - Renal: Creatinine normal - Cardiovascular: Adequate cardiac function; No active cardiac disease - Other: Not pregnant; Fertile patients must use effective contraception; No other serious medical or psychiatric disease; No prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
T.R.J.Evans, Study Chair, Scottish Cancer Therapy Network
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066780; SCTN-BR9809,EU-98053
Study Start Date: November 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003679
Other Inflammatory Breast Cancer Studies:
1. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
2. Biological Therapy in Treating Women With Metastatic Breast Cancer
3. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
4. Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
5. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
Related Studies:
Other inflammatory breast cancer Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Combination Chemotherapy in Treating Women With Breast Cancer
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