Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

Conditions

• Hormone-sensitive Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OSI-906 — DRUG
  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
• Erlotinib — DRUG
  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
• Letrozole — DRUG
  In a pill form, by mouth, once per day at 2.5 mg/d.
• Goserelin — DRUG
  For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.

Study Details

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.

Key Dates

First listed

Sep 20, 2010

Start date

May 31, 2010

Status verified

Aug 2012

Primary completion

Jul 31, 2011

Completion

Jul 31, 2011

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: OSI-906 + Erlotinib + Letrozole + Goserelin
  * 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

Primary Outcome Measure

Anti-tumor Activity of OSI-906 [ Time Frame: From study entry to 6 months ]

Locations (3)

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