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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Terminated
CT.gov ID
NCT00634634
Collaborator
Rutgers Cancer Institute of New Jersey (Other), National Cancer Institute (NCI) (NIH), Bayer (Industry), Novartis Pharmaceuticals (Industry)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 11, 2008
Actual Primary Completion Date :
Apr 20, 2019
Actual Study Completion Date :
Apr 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sorafenib and Letrozole

Drug: 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.
Other Names:
  • Nexavar
  • Drug: Letrozole
    Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
    Other Names:
  • Femara
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [3 years]

    Secondary Outcome Measures

    1. 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 [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Georgetown University Hospital Washington District of Columbia United States 20007
    2 Emory University Atlanta Georgia United States 30322
    3 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    4 Cooper Hospital/University Medical Center Voorhees New Jersey United States 08690

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • Rutgers Cancer Institute of New Jersey
    • National Cancer Institute (NCI)
    • Bayer
    • Novartis Pharmaceuticals

    Investigators

    • Principal Investigator: Antoinette Tan, MD, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deborah Toppmeyer, MD, Professor of Medicine, Chief Medical Officer, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT00634634
    Other Study ID Numbers:
    • 0220070284/Pro2018001861
    • NJ 1107
    • 0220070284
    • NCI-2012-00525
    • 040706
    • Pro2018001861
    First Posted:
    Mar 13, 2008
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Deborah Toppmeyer, MD, Professor of Medicine, Chief Medical Officer, Rutgers, The State University of New Jersey
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2021