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Sorafenib in Treating Patients With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096434
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: sorafenib tosylate
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, Open Label
Official Title: Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2004
Detailed Description:

OBJECTIVES:

  • Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.
  • Assess the toxicity profile of this drug in these patients.
  • Determine time to disease progression and survival time of patients treated with this drug.
  • Correlate pre-treatment levels of activated ERK1/2 with tumor response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months until disease progression and then every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 20-42 patients will be accrued for this study within 5-18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Clinical evidence of metastatic disease
  • Measurable disease
  • HER2-positive or -negative disease

    • If HER2 gene amplified or strongly positive for HER2 by immunohistochemistry, patient must have had prior treatment containing trastuzumab (Herceptin®) unless contraindicated
  • Previously treated with anthracycline- and/or taxane-containing regimen in the neoadjuvant, adjuvant, or metastatic setting
  • Candidate for first- or second-line chemotherapy for metastatic disease
  • Core block or tumor slides of the primary or metastatic tumor available
  • No known brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • PT normal
  • PTT normal
  • INR normal

Renal

  • Creatinine ≤ 1.5 times ULN
  • Calcium normal

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension

Gastrointestinal

  • No gastrointestinal tract disease that would preclude taking oral medication
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 4 weeks since prior immunotherapy
  • No concurrent anticancer immunotherapy
  • No concurrent bevacizumab

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting is allowed
  • No concurrent anticancer hormonal therapy

Radiotherapy

  • No prior radiotherapy to ≥ 25% of the bone marrow
  • More than 4 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery
  • No prior surgical procedure that would affect gastrointestinal absorption

Other

  • No other concurrent drugs that target vascular endothelial growth factor (VEGF) or VEGF receptors
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:

    • Phenytoin
    • Carbamazepine
    • Phenobarbital
  • No concurrent rifampin
  • No concurrent Hypericum perforatum (St. John's wort)
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial devices is allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096434

  Show 172 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
Investigator: Roscoe F. Morton, MD, FACP John Stoddard Cancer Center at Iowa Methodist Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
Pockaj BA, Mukherjee P, Tinder TL, et al.: NCCTG N0338: effect of docetaxel and carboplatin on VEGF, PGE2, and immune cells in patients with stage II or III breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-5110, 2008.
Reinholz MM, Kitzmann KK, Hillman D, et al.: Differential gene expression in circulating tumor cells between primary and metastatic breast cancer patients. [Abstract] Breast Cancer Res Treat 106 (1): A-5022, S213-4, 2007.

Study ID Numbers: CDR0000393224, NCCTG-N0336
Study First Received: November 9, 2004
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00096434  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Taxane
Sorafenib
Breast Diseases
Recurrence

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 16, 2009