Clinical trial · Interventional
Sorafenib in Treating Patients With Metastatic Breast Cancer
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
NCT00096434CI-TRIAL-00074791completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: sorafenib tosylate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Proportion of confirmed tumor responses, graded according to RECIST criteria
- timeFrame
- Up to 5 years
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.