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

NCT01205685 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2012-09-11

Study results available
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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.

Conditions

  • Hormone-sensitive Metastatic Breast Cancer

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Ingrid Mayer, M.D. · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01205685 on ClinicalTrials.gov