Clinical trial NCT00634634: Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Breast Cancer
Keywords: breast cancer
Postmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: National Cancer Institute (NCI)
name: Bayer
name: Novartis Pharmaceuticals
First posted: 2008-03-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
timeFrame: twenty eight days
Secondary outcomes:
measure: Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib
timeFrame: 6 months
measure: Median Progressive-Free Survival (PFS)
timeFrame: Approximately 4.6 years
measure: Overall Survival (OS) Assessed as Mean Months
timeFrame: Approximately 4.6 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Antoinette Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: