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.

Condition	Treatment or Intervention	Phase
stage IIIB breast cancer stage IIIA breast cancer inflammatory breast cancer stage II breast cancer	Procedure: chemotherapy  Drug: capecitabine  Drug: cyclophosphamide  Drug: epirubicin	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years   -   70 Years

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

Switzerland
      Hopital Cantonal Universitaire de Geneva, Geneva,  CH-1211,  Switzerland

Study chairs or principal investigators

Herve Bonnefoi,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000068365; IDBBC-10991-CEX; EORTC-10991
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008034
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08