NCT00877500

Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy

A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.

Detailed description

PRIMARY OBJECTIVES: I. To investigate the genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors that do not achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) and correlate these features with outcome in the presence and absence of adjuvant ixabepilone. II. To evaluate the presence of circulating tumor cells (CTCs) at baseline (before chemotherapy starts; if radiation is used, after radiation ends), during and after ixabepilone therapy or during observation. SECONDARY OBJECTIVES: I. To collect serial blood samples for future pharmacogenomic studies. II. To determine if the addition of adjuvant ixabepilone will improve recurrence-free survival in patients that have significant residual HER 2/neu-negative breast cancer after NST. III. To assess the toxicity of adjuvant ixabepilone in this group of patients. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (IXABEPILONE): Participants receive ixabepilone intravenously (IV) over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. GROUP II (STANDARD OF CARE): Participants receive standard of care for 18 weeks. After completion of study treatment, participants are followed up every 3 months for 2 years and every 6 months for 3 years.

Conditions

• Bilateral Breast Carcinoma
• HER2/Neu Negative
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
DRUG	Ixabepilone	Given IV

Timeline

• Start date: 2009-03-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2009-04-07
• Last updated: 2025-11-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study