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Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

NCT00611715 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-08-09

Study results available
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Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.

Conditions

Interventions

DRUG

erlotinib hydrochloride

OSI-774 150 mg/day

DRUG

letrozole

Letrozole 2.5 mg/day

GENETIC

fluorescence in situ hybridization

To determine HER2 gene amplification or excess copies of the HER2 gene

OTHER

immunohistochemistry staining method

to measure the epidermal growth factor receptors (EGFR)

OTHER

laboratory biomarker analysis

To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Ingrid Mayer, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00611715 on ClinicalTrials.gov