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

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ClinicalTrials.gov Identifier: NCT00525161
Recruitment Status : Terminated (Slow accrual and loss of funding)
First Posted : September 5, 2007
Results First Posted : January 13, 2015
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
Suleiman Massarweh, University of Kentucky

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: sorafenib Phase 2

Detailed Description:
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Primary Completion Date : January 2013
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sorafenib & Endocrine Therapy
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

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 12 weeks after treatment & 8 weeks after initial documentation of response ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.

Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: continuously ]
  2. Clinical Benefit Rate [ Time Frame: 24 weeks ]
    Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  • Eastern Cooperative Oncology Group (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 ≥ Common Toxicity Criteria for Adverse Effects (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525161

United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Suleiman Massarweh
Principal Investigator: Suleiman Massarweh, MD University of Kentucky

Responsible Party: Suleiman Massarweh, Clinical Faculty, Internal Medicine / Oncology, University of Kentucky
ClinicalTrials.gov Identifier: NCT00525161     History of Changes
Other Study ID Numbers: 07-BRE-41-BP
First Posted: September 5, 2007    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Suleiman Massarweh, University of Kentucky:
breast cancer
Endocrine Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs