Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer male breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

* The primary objective of this study is to assess the antitumor activity, measured by tumor response rate, in patients who receive this regimen as a third-line treatment. (Phase II)

Secondary

* To measure the duration of response for responding patients.
* To measure the time to progressive disease.
* To measure survival time.
* To characterize the quantitative and qualitative toxicities of this regimen in these patients.
* To develop pharmacodynamic markers for autophagy detection in patient specimens.
* To characterize the effects of hydroxychloroquine on autophagy in patients in vivo.
* To investigate whether the estrogen receptor, progesterone receptor, and/or HER2 status of breast tumors correlates with treatment response.

OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a phase II study.

During the first course, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 3-21. On all subsequent courses, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

Arms:
arm 1: None

Interventions: intervention 1: hydroxychloroquine intervention 2: ixabepilone
Intervention descriptions: intervention 1: Dose escalation from 200 mg po qd to 200 mg po bid. intervention 2: Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

Protocol document: