A phase III trial to evaluate oral chemotherapy with capecitabine versus standard chemotherapy with CMF for advanced breast cancer (ANZ 0001 Capecitebine)
Breast Cancer Trials (BCT)Dataset description
323 eligible women were randomly assigned to capecitabine adminis-tered intermittently (1,000 mg/m2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophos-phamide 100 mg/m2 days 1 to 14 with intravenous methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P >.05), combined for definitive comparisons versus CMF.Date Information
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
ANZ 0001(Capecitabine)
Trial ID
ACTRN12606000379516
Funding
Commercial sector/Industry, Roche Products Pty Ltd
Scientific enquiries
Australian New Zealand Breast Cancer Trials Group National Group Coordinator - Professor John F Forbes
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.
Key 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 g .... Read more
Key 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 .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 325
Min. age 18 Years
Max. age No limit
Sex Females
Condition category Advanced breast cancer
Condition code Cancer
Intervention
Intervention code Treatment: Drugs
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) .... Read more
Comparison
Control group Active
Standard CMF (CMF) Standard intermittent combination chemotherapy with oral cyclophosphamide 100mg/m2 days 1-14, methotrexate 40mg/m2 IV days 1 and 8, 5-Fluorouracil 600mg/m2 IV days 1 and 8 reviewed and repeated every 4 weeks. There is no dose escalation. Prednisone 40 mg /m2 p.o. days 1-14 may be used with CMF at the investigators discretion; this intention must be documented prior to randomisation.
Outcomes
Outcome: The primary objective is to compare oral chemotherapy with capecitabine to standard intermittent combination chemotherapy with CMF in terms of quality adjusted time to progressionTimepoint: quality adjusted time to progression
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial.
When will data be available?
Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.
Available to whom?
Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines.
Available for what types of analyses?
To achieve the aims in the approved proposal.