Data

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.
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Subjects

Chemotherapy |

Related Study

ANZ 0001 Capecitabine vs CMF in Advanced Breast Cancer

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.

Conditions

Condition Codes

Intervention Code

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.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Available

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.