Breast cancer Cancer Metastatic neoplasm of the breast
Conditions
Interventions
Arm 1: Paclitaxel (90 mg/m^2 intravenous [IV] over 1 hour on day 1 every week for 12 cycles)
Arm 2: Paclitaxel (175 mg/m^2 IV over 3 hours on day 1 every 3 weeks for 6 cycles)
Sponsors
Anglo Celtic Cooperative Oncology Group (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antitumour efficacy, as determined by the time to disease progression 2. Polymorphisms in the genes responsible for paclitaxel metabolism, response rates and toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity 2. Response rate 3. Overall survival 4. Quality of life | — |
Countries
United Kingdom
Outcome results
None listed