Metastatic or advanced breast cancer, second line chemotherapy
Conditions
Interventions
Two different regimens.
Sponsors
Sanofi-Aventis
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven breast adenocarcinoma; 2. Evaluable or measurable disease according to RECIST criteria; 3. Metastatic progressive breast cancer; 4. No more than 1 line of chemotherapy for metastatic disease; 5. Radiotherapy is allowed, no minimum time interval between the end of radiotherapy and study entry , however the irradiated lesion must not be the only lesion to evaluate response; 6. Performance status ECOG 3,5 x ULN associated with ALP>6x ULN are not eligible for study. 8. Written informed consent given; 9. Age >18 years. • Compliance with follow up requirements
Exclusion criteria
Exclusion criteria: 1. ECOG > 2; 2. Prior exposure to taxanes for metastatic disease; 3. Patient who received two or more lines of prior chemotherapy for metastatic disease; 4. Inadequate bone marrow function: A. Neutrophils UNL; 6. Concurrent severe and/or co-morbid medical condition; 7. Concurrent treatment with other experimental drugs or clinical trials; 8. Definite contraindications for the use of corticosteroïds; 9. Pregnant or lactating women; 10. Symptomatic peripheral neuropathy > NCI-CTC grade II; 11. Hormonal treatment (prior hormonal treatment allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PFS; 2. TTF. | — |
Contacts
Public ContactA.M. Westermann
AMC Dept Medical Oncology
Outcome results
None listed