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

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	6/16/2018
Start Date:	August 11, 2008
End Date:	May 2019

Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer

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.

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

We found this trial at

sites

Georgetown University Hospital

3800 Reservoir Rd NW
Washington, District of Columbia 20007

(202) 444-2000