Conditions: Hormone-sensitive Metastatic Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the laboratory show that OSI-906 can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers.

Detailed description:
The safety run component of this trial is to determine the safety profile of the OSI-906, erlotinib and anti-endocrine treatment combination. The phase II component evaluates the antitumor activity of the combination OSI-906, erlotinib and endocrine therapy.

Arms:
arm 1: * OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal

Interventions: intervention 1: OSI-906 intervention 2: Erlotinib intervention 3: Letrozole intervention 4: Goserelin
Intervention descriptions: intervention 1: In a pill form by mouth, twice a day (12 hours apart)

During the safety run portion of the study"

* Dose level 2 = 150 mg twice a day
* Dose level 1 = 100 mg twice a day
* Dose level -1 = 100 mg twice a day
* Dose level -2 = 100 mg twice a day intervention 2: During the safety run phase of the study:

* Dose Level 2 = 100 mg/d
* Dose Level 1 = 100 mg/d
* Dose Level -1= 75 mg/d
* Dose Level -2 = 50 mg/d intervention 3: In a pill form, by mouth, once per day at 2.5 mg/d. intervention 4: For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.

Protocol document: