Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
