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Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00525161
First received: September 3, 2007
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

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 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sorafenib & Endocrine Therapy
 Drug: sorafenib
400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Other Name: Nexavar

  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

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Bayer
Investigators
Principal Investigator: Suleiman Massarweh, MD University of Kentucky
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00525161     History of Changes
Other Study ID Numbers: 07-BRE-41-BP
Study First Received: September 3, 2007
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013