Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.

Secondary

* To determine the median time to progression in these patients.
* To determine the response duration and survival in these patients.
* To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Arms:
arm 1: Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.

Interventions: intervention 1: Etoposide intervention 2: Irinotecan hydrochloride
Intervention descriptions: intervention 1: 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle intervention 2: Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Protocol document: