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Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
This study is currently recruiting participants.
Verified by University of Kentucky, May 2008
Sponsors and Collaborators: University of Kentucky
Bayer
Information provided by: University of Kentucky
ClinicalTrials.gov Identifier: NCT00525161
  Purpose

The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: sorafenib
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 weeks after treatment & 8 weeks after initial documentation of response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: continuously ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Correlation between biomarkers and treatment outcome [ Time Frame: assessed after treatment response determined ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Sorafenib & Endocrine Therapy
Drug: sorafenib
400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

  Eligibility

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

Inclusion Criteria:

  • All subjects must be female.
  • Age ≥ 18 years old.
  • Histologically proven carcinoma of the breast.
  • Estrogen receptor and/or Progesterone positive disease.
  • Metastatic or locally advanced disease.
  • Patients on a preexisting endocrine agent for at least 3 months before enrollment.
  • Have residual measurable disease after

    1. maximal response to endocrine therapy or
    2. no response to endocrine therapy or
    3. progressive non-visceral disease on endocrine therapy.
  • Must be able to provide a tumor block from either the primary or metastatic site, if available.
  • ECOG Performance Status 0-2.
  • Adequate organ function.

Exclusion Criteria:

  • Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
  • Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
  • Prior use of anti-angiogenic agents.
  • As judged by the investigator, uncontrolled intercurrent illness.
  • Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • A serious non-healing wound or ulcer.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
  • Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within the 4 weeks prior to the first dose of study drug.
  • Pregnancy
  • Any condition that impairs patient's ability to swallow whole pills.
  • Documented malabsorption problem.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525161

Contacts
Contact: Vera Kadamyan-Melkumyan 859-257-3379 vgkada0@email.uky.edu
Contact: Suleiman A Massarweh, M.D. 859-323-6562 Massarweh@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Vera Kadamyan     859-257-3379     vgkada0@email.uky.edu    
Contact: Suleiman A Massarweh, M.D.     859-323-6562     Massarweh@uky.edu    
Sponsors and Collaborators
University of Kentucky
Bayer
Investigators
Principal Investigator: Suleiman Massarweh, MD University of Kentucky
  More Information

Responsible Party: University of Kentucky ( Suleiman A Massarweh, M.D. )
Study ID Numbers: 07-BRE-41-BP
Study First Received: September 3, 2007
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00525161  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
breast cancer
Sorafenib
Nexavar
Endocrine Therapy

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Sorafenib
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009