Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 6, 2009
Last updated: July 12, 2013
Last verified: July 2013
The goal of this clinical research study is to learn about certain genes and proteins in tumors that do not respond well to treatment. These features will be compared with the status of the disease after surgery for breast cancer that does not express the HER2 protein, when patients either receive or do not receive ixabepilone. The safety of ixabepilone in this group of patients will also be studied.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Genomic (transcriptional profiles) + Proteomic (pathway activation) Tumor Features [ Time Frame: Blood tests Day 1 of each 21-day cycle (up to 6 cycles) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of Circulating Tumor Cells (CTCs) [ Time Frame: At time of surgery, during and after ixabepilone therapy or during observation. ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||April 2020 (Final data collection date for primary outcome measure)
Experimental: Group 1 Ixabepilone
Ixabepilone 40 mg/m^2 by vein over 3 hours on Day 1 of each 21-day study cycle for up to 6 cycles.
40 mg/m^2 by vein over 3 hours on Day 1 of each 21-day study cycle for up to 6 cycles.
- Epothilone B analogue
No Intervention: Group 2 Observation
Standard of care treatments for disease.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (IHC 0-1+ or FISH-negative) that have received complete anthracycline and taxane neoadjuvant systemic therapy and that at the time of surgery are expected to have significant residual disease. Therapy should include at least 4 cycles of an anthracycline-based regimen (AC, FAC, FEC) and 12 weeks of a taxane-based regimen (weekly paclitaxel, every 3-week docetaxel).
- Patients who did not complete therapy due to disease progression are eligible.
- Age >/= 18 years
- Patients with bilateral breast cancers are eligible.
- Patients should have a Karnofsky performance scale of =/> 70%.
- Patient should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1500/mm^3, and platelet count >/= 100000 mm^3.
- Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution.
- Patients should have adequate renal function with creatinine levels within normal range.
- Negative serum pregnancy test for a woman of childbearing potential.
- Women of childbearing potential (WOCP) must use a reliable and appropriate contraceptive method during the study and 6 months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.
- Patients must agree to have study tissue collections and blood sample collections.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
- Patients should have their surgical tissues evaluated for RCB and be used for correlative studies.
- Sexually active women of childbearing potential must use an effective method of birth control during the course fo the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
- All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The PI will immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
- Patients whose tumors express HER2 protein or have HER2/neu gene amplification.
- Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
- Patients with a pre-existing peripheral neuropathy > grade 1.
- Evidence of distant metastases
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877500
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Funda Meric-Bernstam, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 6, 2009
||July 12, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
HER2/neu-negative Breast Cancer
Residual Breast Cancer
Neoadjuvant Systemic Therapy
Epothilone B analogue
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action