ACTRN12606000379516
Completed
Phase 3
A phase III trial to evaluate oral chemotherapy with Capecitabine versus standard chemotherapy with CMF in advanced breast cancer
Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)0 sites325 target enrollmentDecember 17, 2003
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)
- Enrollment
- 325
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologic or cytologic diagnosis of breast cancer with at least one of the following: distant metastasis (including just supraclavicular nodes), local invasion of adjacent non\-breast tissue ie T4 or N2 or N3, local recurrence following mastectomy; Treatment with palliative intent, i.e. without realistic hope of cure; Suitable for protocol chemotherapy with either CMF or capecitabine; ECOG performance status of 0 to 3; Neutrophil count greater than or equal to 1\.5 x 10 (9\)/L and Platelet count greater than or equal to 75 x 10 (9\)/L; Creatinine clearance greater than or equal to 30 mL/minute according to the Cockcroft\-Gault Formula; Serum total bilirubin \<50 umol/L; Accessible for treatment and follow\-up; Written informed consent; Baseline HRQL forms completed OR the patient cannot read English.
Exclusion Criteria
- •Previous chemotherapy for advanced breast cancer; Less than 6 months following the last dose of adjuvant chemotherapy; Unsuitable for protocol therapy with either CMF or capecitabine, e.g. side effects with 5 FU suggestive of dihydropyrimidine dehydrogenase deficiency; GI disease precluding oral chemotherapy; serious uncontrolled infection; Indication for chemotherapy more intensive than CMF or capecitabine; Brain and/or leptomeninges as the only sites of documented disease; Age \<18 years (there is no upper age limit); Pregnant or breast\-feeding women; Investigational drug therapy within 30 days prior to randomisation; Concurrent anticancer therapy (any radiation must be completed at least 4 weeks before randomisation); Other malignancy within the last 5 years except adequately treated basal cell or squamous cell carcinoma of skin or in\-situ carcinoma of the cervix; Treatment with the antiviral agent sorivudine, or related compounds such as brivudine
Outcomes
Primary Outcomes
Not specified
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