Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-11

Study Completion Date

2023-04-28

Brief Summary

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Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib and Letrozole

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.

Letrozole

Intervention Type DRUG

Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28

Interventions

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Sorafenib

sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.

Intervention Type DRUG

Letrozole

Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28

Intervention Type DRUG

Other Intervention Names

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Nexavar Femara

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed invasive breast cancer
2. Stage IIIB, IIIC with T4 lesion or Stage IV disease
3. Breast cancer must be ER-positive and/or PR-positive
4. Age ³ 18 years of age
5. ECOG performance status 0, 1 or 2
6. Able to swallow and oral medication
7. Adequate end organ function
8. Written informed consent

Exclusion Criteria

1. Prior hormonal therapy for metastatic disease
2. Prior chemotherapy for metastatic disease
3. Prior treatment with sorafenib
4. Brain metastases or leptomeningeal disease
5. Evidence or history of bleeding
6. Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Deborah Toppmeyer, MD

Professor of Medicine, Chief Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoinette Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Cooper Hospital/University Medical Center

Voorhees Township, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document