A randomised two-arm, prospective, multi-centre, open-label phase III trial comparing the activity and safety of a weekly versus a three-weekly paclitaxel treatment schedule in patients with advanced or metastatic breast cancer
Phase 3
Completed
- Conditions
- Breast cancerCancerMetastatic neoplasm of the breast
- Registration Number
- ISRCTN52817670
- Lead Sponsor
- Anglo Celtic Cooperative Oncology Group (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
1. Histologically proven breast cancer
2. Locally advanced or metastatic disease
3. Presence of measurable or evaluable lesions
4. Prior treatment with anthracyclines (either in the adjuvant setting or for metastatic disease) or contraindication to anthracyclines
5. Aged 18 years or greater
6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
7. Adequate haematological, renal and hepatic function
8. Written informed consent
Exclusion Criteria
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Antitumour efficacy, as determined by the time to disease progression<br> 2. Polymorphisms in the genes responsible for paclitaxel metabolism, response rates and toxicity<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Toxicity<br> 2. Response rate<br> 3. Overall survival<br> 4. Quality of life<br>