Sorafenib in Treating Patients With Metastatic Breast Cancer

NCT00096434 | Completed Phase 2

• 5 other identifiers: NCI-2012-01817CDR0000393224NCCTG-N0336N0336U10CA025224
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of confirmed tumor responses, graded according to RECIST criteria

  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.

  Up to 5 years

Secondary Outcomes (3)

• Time to progression

  Time from registration to disease progression, assessed up to 5 years

• Survival time

  Time from registration to death, assessed up to 5 years

• Incidence of adverse events, graded according to the NCI-CTC version 3

  Up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

sorafenib tosylate DRUG

Given orally

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Edith Perez

  North Central Cancer Treatment Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 10, 2004
• Study Start: September 1, 2004
• Primary Completion: June 1, 2006
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

US (1)