None listed
Conditions
Brief summary
Chemotherapy can improve both the length and qualtiy of life in women with advanced breast cancer, however the best approach is unclear for women unsuited to intensive chemotherapy. This randomised trial aims to find out whether simple daily oral chemotherapy (Capecitabine) or standard chemotherapy including injections (CMF) is best for such women. The study looks at the effects of disease and treatment on both length and quality of life.
Interventions
ANZ 0001 is an unblinded, multicentre, randomized phase III clinical trial of 465 women with advance disease and not suited to intensive chemotherapy. This study aims to determine whether daily oral chemotherapy with capecitabine is preferable to standard intermittent chemotherapy with CMF in such people.
This trial has 3 treatment arms: Intermittent Capecitabine; Continuous Capecitabine; Standard CMF (CMF) - (oral cyclophosphamide days 1-14; methotrexate and 5-Fluorouracil both IV days 1 and
ANZ 0001 is an unblinded, multicentre, randomized phase III clinical trial of 465 women with advance disease and not suited to intensive chemotherapy. This study aims to determine whether daily oral chemotherapy with capecitabine is preferable to standard intermittent chemotherapy with CMF in such people. This trial has 3 treatment arms: Intermittent Capecitabine; Continuous Capecitabine; Standard CMF (CMF) - (oral cyclophosphamide days 1-14; methotrexate and 5-Fluorouracil both IV days 1 and 8) Intermittent Capecitabine (IC) Intermittent daily oral chemotherapy with capecitabine 2000 mg/m2/day days 1-14, reviewed and repeated every 3 weeks. The dose of capecitabine is increased to 2500 mg/m2/day if there is no toxicity equal to or greater than grade 1 in cycles 1 and 2. Patients with moderate renal impairment (calculated creatinine clearance of 30 - 50 mL/minute) should not have their dose escalated above 2000 mg/m2 per day. Or Continuous Capecitabine (CC) Continuous daily oral chemotherapy with capecitabine 1300 mg/m2/ day days 1-21 reviewed and repeated every 3 weeks. There is no dose escalation.
Sponsors
Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed