Advanced breast cancer Cancer Breast cancer
Conditions
Interventions
100 mg/m^2/day cyclophosphamide days 1 - 14 plus capecitabine 1331 mg/m^2/day days 1 - 28, every 28 days versus capecitabine 1331 mg/m^2/day days 1-28, every 28 days alone.
Sponsors
Cancer Trials New Zealand (CTNZ) (New Zealand)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with advanced breast cancer (distant metastasis, or T4, N2 or N3, or local recurrence following mastectomy) 2. Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) 3. Treatment with palliative intent 4. At least one prior course of chemotherapy for advanced disease
Exclusion criteria
Exclusion criteria: Added as of 16/12/2008: 1. Male 2. Less thank six months since last dose of adjuvant chemotherapy 3. More than one prior regimen for advanced disease 4. Pregnant or breast feeding 5. Concurrent anti-cancer therapy 6. Other malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 16/12/2008: 1. Toxicity assessed thoughout treatment, assessed 8-weekly during the treatment period 2. Best tumour response, assessed 8-weekly during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 16/12/2008: 1. Survival measures, assessed at completion of the study 2. Symptom response, assessed throughout treatment | — |
Countries
New Zealand
Outcome results
None listed