Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877500
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : August 11, 2017
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ixabepilone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2009
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone

Arm Intervention/treatment
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.
Drug: Ixabepilone
40 mg/m^2 by vein over 3 hours on Day 1 of each 21-day study cycle for up to 6 cycles.
Other Names:
  • BMS-247550
  • Epothilone B analogue

No Intervention: Group 2 Observation
Standard of care treatments for disease.

Primary Outcome Measures :
  1. Genomic (transcriptional profiles) + Proteomic (pathway activation) Tumor Features [ Time Frame: Blood tests Day 1 of each 21-day cycle (up to 6 cycles) ]
    Signaling pathway analysis through reverse phase protein arrays (RPPA) used to objectively quantify (phospho) protein expression. Functional activation of the pathway defined as an increase in phosphorylation of at least one half of the components of each pathway above the median RPPA quantified activation across the entire tumor set.

Secondary Outcome Measures :
  1. Number of Circulating Tumor Cells (CTCs) [ Time Frame: At 18 weeks (+/- 7 days) of therapy following surgery ]
    Number of Circulating Tumor Cells defined as the presence of any cell per 7.5 ml of whole blood.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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).
  2. Patients who did not complete therapy due to disease progression are eligible.
  3. Age >/= 18 years
  4. Patients with bilateral breast cancers are eligible.
  5. Patients should have a Karnofsky performance scale of =/> 70%.
  6. Patient should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1500/mm^3, and platelet count >/= 100000 mm^3.
  7. 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.
  8. Patients should have adequate renal function with creatinine levels within normal range.
  9. Negative serum pregnancy test for a woman of childbearing potential.
  10. 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.
  11. Patients must agree to have study tissue collections and blood sample collections.
  12. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
  13. Patients should have their surgical tissues evaluated for RCB and be used for correlative studies.
  14. 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.
  15. 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.

Exclusion Criteria:

  1. Patients whose tumors express HER2 protein or have HER2/neu gene amplification.
  2. 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
  3. 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)
  4. Patients with a pre-existing peripheral neuropathy > grade 1.
  5. Evidence of distant metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877500

United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00877500     History of Changes
Other Study ID Numbers: 2008-0435
NCI-2010-01033 ( Registry Identifier: NCI CTRP )
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents