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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer  Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
For Condition: stage 3B breast cancer,inflammatory breast cancer,stage 2 breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
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 and shrink tumors so they can be removed during surgery. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced , inflammatory, or large surgically removable breast cancer.
Details: OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and epirubicin in women with locally advanced or inflammatory or large operable breast cancer. II. Determine the maximum tolerated dose of this regimen in this patient population. PROTOCOL OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed carcinoma of the breast; Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large operable disease (large T2 or T3 for which tumor shrinkage is needed) - No distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes; No abnormal bone scintigrams that cannot be confirmed as benign - Hormone Receptor Status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 to 70 - Sex: Female - Menopausal status: Not specified - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN); SGOT no greater than 2 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: LVEF normal by echocardiography or MUGA - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other serious uncontrolled illnesses; No uncontrolled psychiatric or addictive disorders; No other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HerveBonnefoi, Study Chair, National Cancer Institute (NCI)
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
Additional Information:
Study ID Numbers: CDR0000068365; IDBBC-10991-CEX,EORTC-10991
Study Start Date: February 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008034
Other Stage 3a Breast Cancer Studies:
1. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
2. Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
3. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
4. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed 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
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Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
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