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

This study is currently recruiting participants.

Verified by University of Medicine and Dentistry New Jersey, March 2008

First Received: March 5, 2008 Last Updated: March 12, 2008 History of Changes

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Cancer Institute of New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00634634

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Sorafenib Drug: Letrozole	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634634

Contacts

Contact: Lien Huzzy, RN, BSN, OCN

732-235-8962

tanglb@umdnj.edu

Locations

United States, New Jersey
Cancer Institute of New Jersey	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Lien Huzzy, RN, BSN, OCN 732-235-8962 tanglb@umdnj.edu

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Cancer Institute of New Jersey

Investigators

Principal Investigator:

Antoinette Tan, MD

UMDNJ/CINJ

More Information

No publications provided

Responsible Party:	Cancer Institute of New Jersey/UMDNJ ( Antoinette Tan, MD )
Study ID Numbers:	040706, NJ 1107
Study First Received:	March 5, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00634634 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

breast cancer
Postmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Letrozole
Aromatase Inhibitors

Protein Kinase Inhibitors
Hormones
Sorafenib
Menopause
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors
Letrozole
Protein Kinase Inhibitors

Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Sorafenib
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009