Breast Neoplasms
Conditions
Brief summary
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.
Interventions
DRUGIrinotecan
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with diagnosis of primary adenocarcinoma of the breast * Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent * At least one measurable lesion \>20mm (or \>10 mm with spiral CT scan) * Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting * Women at least 18 years old, with performance status 0-2
Exclusion criteria
* Prior treatment with another topoisomerase I inhibitor * Current enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of Irinotecan in refractory breast cancer. | — |
Countries
Argentina, Australia, Colombia, New Zealand, United States
Outcome results
None listed