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Brief Title: Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer
Official Title: A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) and Erlotinib (Tarceva®, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer
Study ID: NCT01205685
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Vanderbilt-Ingram Oncology Cool Springs, Franklin, Tennessee, United States
Vanderbilt One Hundre Oaks, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Name: Ingrid Mayer, M.D.
Affiliation: Vanderbilt-Ingram Cancer Center
Role: PRINCIPAL_INVESTIGATOR