ANZ 8614: A phase III randomised trial of mitozantrone versus CMFP (cyclophosphamide, methotrexate, 5-flourouracil, prednisone) in advanced breast cancer – a quality of life study

ANZ 8614 is a phase III study evaluating mitozantrone versus CMFP in advanced breast cancer, with respect to patient quality of life. Eligible patients shall be randomised to one of two treatment arms: Arm A: mitozantrone initially, followed by second-line CMFP upon relapse (after previous response) or disease progression Arm B: CMFP initially, followed by second-line mitozantrone upon relapse (after previous response) or disease progression For both Arms (at the appropriate stage), mitozantrone is administered intravenously on day 1 of 21 day cycles at 14 mg per metre squared. For both Arms (at the appropriate stage), CMF is administered in 28 day cycles as: * cyclophosphamide, p.o. at 100 mg per square metre, on days 1-14 (inclusive); * methotrexate, i.v. at 40 mg per square metre, on day 1 and day 8; * 5-flourouracil, i.v. at 600 mg per square metre, on day 1 and day 8; * prednisone, p.o. at 40 mg per square metre, on days 1-14 (inclusive); All drug doses are based on the lesser of the patient’s ideal versus actual weight, and are subject to dose modifications (ie for toxicity) as specified in the protocol. The same treatment duration criteria apply to both initial and second-line therapy, as follows: * Mitozantrone treatment should continue until: - disease progression, OR - patient intolerance or unacceptable toxicity, OR - cumulative dose of 140 mg per square metre is reached; (a greater cumulative dose is allowed at the discretion of the investigators, with cardiac monitoring). * CMFP treatment should continue until: - disease progression, OR - patient intolerance or unacceptable toxicity, OR - for at least 12 months duration; (a period of more than 12 months may be allowed in suitable patients, at the discretion of the investigator).