Phase 2, Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-sensitive Metastatic Breast Cancer
Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole +/- goserelin (the latter for pre-menopausal women only) may fight breast cancer by lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy and OSI-906 are more effective when given with or without erlotinib hydrochloride in treating hormone-sensitive metastatic breast cancer. PURPOSE: This phase II trial is studying how well giving hormone therapy together with OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients with metastatic breast cancer.
Timeline
- Start
- 2009-08
- Primary completion
- 2009-12
- Completion
- 2009-12
Outcome
Outcome not reported
Stopped (Enrollment): “Study was abandoned before opening to accrual. Replaced by another study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | — | Oral |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |
| Background | Letrozole | Other / unclassified | — | Oral |
| Background | linsitinib | Small molecule | — | Oral |