Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer
Interventions
DRUGPaclitaxel
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Patients with primary advanced inoperable disease who were refractory to chemotherapy * Patients with recurrent disease following post-operative adjuvant chemotherapy * Patients who were not amenable to post-recurrence chemotherapy
Exclusion criteria
* Patients with serious, uncontrolled medical illness * Patients with previous therapy with taxanes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
| Safety: incidence and severity of adverse events, laboratory test abnormalities | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
Outcome results
None listed