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Sorafenib in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 9, 2004
Last updated: October 7, 2013
Last verified: October 2013
This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Proportion of confirmed tumor responses, graded according to RECIST criteria [ Time Frame: Up to 5 years ]
    A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. A 90% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Time from registration to disease progression, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method.

  • Survival time [ Time Frame: Time from registration to death, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method.

  • Incidence of adverse events, graded according to the NCI-CTC version 3 [ Time Frame: Up to 5 years ]
    The maximum grade for each type of toxicity will be recorded for each patient at each treatment evaluation. The frequency of each type of toxicity will be determined.

Estimated Enrollment: 42
Study Start Date: September 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Given orally
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


I. Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.

II. Assess the toxicity profile of this drug in these patients. III. Determine time to disease progression and survival time of patients treated with this drug.

IV. 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.


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

Inclusion Criteria:

  • 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
  • Male or female
  • Performance status - ECOG 0-1
  • At least 3 months
  • 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
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • PT normal
  • PTT normal
  • INR normal
  • Creatinine ≤ 1.5 times ULN
  • Calcium normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • No gastrointestinal tract disease that would preclude taking oral medication
  • No active peptic ulcer disease
  • 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
  • See Disease Characteristics
  • More than 4 weeks since prior immunotherapy
  • No concurrent anticancer immunotherapy
  • No concurrent bevacizumab
  • 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
  • Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting is allowed
  • No concurrent anticancer hormonal therapy
  • No prior radiotherapy to ≥ 25% of the bone marrow
  • More than 4 weeks since prior radiotherapy
  • More than 4 weeks since prior major surgery
  • No prior surgical procedure that would affect gastrointestinal absorption
  • 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
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Please refer to this study by its identifier: NCT00096434

United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Edith Perez North Central Cancer Treatment Group
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00096434     History of Changes
Other Study ID Numbers: NCI-2012-01817
NCI-2012-01817 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N0336 ( Other Identifier: North Central Cancer Treatment Group )
N0336 ( Other Identifier: CTEP )
U10CA025224 ( US NIH Grant/Contract Award Number )
Study First Received: November 9, 2004
Last Updated: October 7, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017