Randomised phase II study comparing capecitabine with oral cyclophosphamide and capecitabine in patients with advanced breast cancer
Completed
- Conditions
- Advanced breast cancerCancerBreast cancer
- Registration Number
- ISRCTN68662102
- Lead Sponsor
- Cancer Trials New Zealand (CTNZ) (New Zealand)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 82
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method