This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments sorafenib, letrozole
Phase phase 1/phase 2
Sponsor Rutgers, The State University of New Jersey
Collaborator Rutgers Cancer Institute of New Jersey
Start date August 2008
End date May 2017
Trial size 54 participants
Trial identifier NCT00634634, 0220070284, 040706, NCI-2012-00525, NJ 1107


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
sorafenib Nexavar
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 Femara
Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28

Primary Outcomes

find phase II dose of study drugs in pts w/hormone receptor-positive locally advanced or metastatic breast ca. find clinical benefit rate (pts who achieve a CR, PR, or SD in the first-line trt of postmenopausal pts.
time frame: 3 years

Secondary Outcomes

time to progression/survival. Assess safety/tolerability. Evaluate growth factor pathways in tumor samples before/after trt. Evaluate change in circulating tumor cells before/after trt. Evaluate change in blood flow before/after treatment
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer
Principal investigator Antoinette Tan, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.