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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

Phase 2
18 Years
Not Enrolling
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

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


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor responses, graded according to RECIST criteria

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Edith Perez

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



North Central Cancer Treatment Group Rochester, Minnesota  55905