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
The Study Drug:
Ixabepilone is designed to work by blocking cell division, which may cause cancer cell
death.
Surgery:
You will have surgery as part of your standard of care. Your tissue will be tested to
measure residual disease (leftover cancer). If there is a low amount of leftover disease,
you will not be eligible to take part in this study.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups.
If you are in Group 1, you will receive ixabepilone. You also will be treated with the
standard of care treatments for the disease, including radiation and/or hormonal therapy (if
appropriate).
If you are in Group 2, you will not receive the study drug. You will be treated with the
standard of care treatments for the disease, including radiation and/or hormonal therapy (if
appropriate).
Study Drug Administration for Group 1:
If you are in Group 1, you will receive ixabepilone though a needle in your vein over 3
hours on Day 1 of each 21-day study cycle.
Before the infusion, you will be given drugs, by vein, to help decrease the risk of an
allergic reaction. These drugs will include Benadryl® (diphenhydramine), Tagamet®
(cimetidine), and Decadron (dexamethasone). The infusion will last 30-45 minutes.
If you experience severe side effects, future treatments may be delayed, the dose may be
decreased, or you may be taken off study.
Study Visits:
Group 1:
On Day 1 of each cycle, the following tests and procedures will be performed:
- Your medical history will be recorded.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a physical exam.
- You will be asked about any side effects you may be experiencing or may have
experienced since the last visit.
Group 2:
At the end of radiation (or on the day of your baseline blood collection), and at Weeks 9
and 18, you will have a physical exam and your medical history will be recorded.
Circulating Tumor Cell (CTC) testing:
Blood (about 2 tablespoons each time) will be drawn before surgery to measure the amount of
CTCs in your blood. If you are in Group 1, blood will be drawn again at Cycles 4 and at the
end of Cycle 6. If you are in Group 2, blood will be drawn again at Weeks 9 and 18.
Length of Study:
If you are in Group 1, you may receive the study drug for up to 6 cycles. You will be taken
off study early if the disease gets worse or intolerable side effects occur.
If you are in Group 2, you will be off study after Week 18.
This is an investigational study. Ixabepilone is FDA approved and commercially available
for metastatic (advanced) breast cancer.
Up to 116 patients will take part in this multicenter study. Up to 116 may be enrolled at
MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Genomic (transcriptional profiles) + Proteomic (pathway activation) Tumor Features
Blood tests Day 1 of each 21-day cycle (up to 6 cycles)
Yes
Ana Gonzalez-Angulo, MD, MS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0435
NCT00877500
April 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |