ANZ 0001 Capecitabine vs CMF in Advanced Breast Cancer

Phase 3

Completed

• Conditions: Advanced breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000379516
• Lead Sponsor: Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-17
• Study Completion: 2013-02-19
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 325

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified