NCT01205685

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone-sensitive Metastatic Breast Cancer

Interventions

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

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-09-20
• Last updated: 2012-09-11
• Results posted: 2012-09-11

Locations

3 sites across 1 country: United States