Metastatic breast cancer patients previously treated with anthracyclines.
Conditions
Interventions
Arm A: weekly paclitaxel 80 mg/m2 i.v.
Arm B (standard arm): three weekly paclitaxel 175 mg/m2 i.v.
- Treatment until progression, unacceptable toxicity.
Sponsors
VU medisch centrum
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed metastatic breast cancer; 2. No past or current history of another neoplastic disease, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri, or other cancers cured by surgery alone and with a disease-free interval of longer than 5 years; 3. Measurable or evaluable metastatic disease outside irradiated areas; lesions in previously irradiated areas can be considered measurable if they are clearly progressing before study entry and the interval between the radiotherapy and the start of protocol treatment exceeds 3 months; 4. Prior treatment with an anthracycline, while further treatment with an anthracycline is judged to be of no benefit; 5. Age ¡Ý 18 and ¡Ü80 years; 6. WHO performance status ¡Ü 2; 7. Life expectancy of at least 3 months; 8. Interval from major surgery, radiotherapy or prior cytotoxic treatment of at least 4 weeks; 9. Patients must have recovered from all adverse effects of prior treatment that could interfere with the antitumor activity or toxicity assessment of the protocol treatment, besides alopecia; 10. Adequate hematologic, renal and hepatic function as defined by the following required laboratory values (obtained ¡Ü 14 days prior to study enrolment): Absolute neutrophil count (ANC) ¡Ý 1.5 x 109/L. Platelets ¡Ý 100 x 109/L. Serum creatinine40 ml/min. Total bilirubin ¡Ü1.5 x upper normal limit. SGOT (ASAT) and/or SGPT (ALAT) ¡Ü 2.5 x upper normal limit; 11. Patients must be assessable for treatment, quality of life and follow-up; 12. Informed consent obtained according to the local Ethics Committee requirements.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with taxanes; 2. Pregnant or breast-feeding females, or females of child-bearing potential not taking adequate methods of birth control; 3. The presence of significant cardiac disease, i.e. hypertension not responding to treatment, unstable angina, congestive heart failure, myocardial infarction within the previous year, cardiac ventricular arrhytmias or a history of a 2nd or 3rd degree heart block without a pacemaker in situ; 4. The presence of CTC grade 2 peripheral neurotoxicity; 5. The presence of leptomeningeal or CNS metastases; 6. Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the patient or interfere with the study objectives, including any other medication that, in the investigators opinion, could compromise the well-being of the patient or the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival; 2. response rate; 3. toxicity; 4. quality of life. | — |
Contacts
Public ContactN. Groeningen, van
VU University Medical Center, Department of Medical Oncology, 3 A 20, P.O. Box 7057
Outcome results
None listed