Can a new drug help when standard chemo leaves cancer behind?
NCT ID NCT00877500
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug ixabepilone can help people with HER2-negative breast cancer who still have significant cancer after standard chemotherapy. About 116 participants will either receive ixabepilone or standard care. The goal is to see if ixabepilone improves outcomes and to understand which tumors might respond best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ixabepilone (a chemotherapy drug that blocks cell division)
- What this could lead to
- If it works, this could provide a new treatment option for breast cancer patients who still have cancer after initial chemotherapy.
- What could go wrong
- This is a small, early-phase trial (116 participants) and may not show a clear benefit. Ixabepilone can cause side effects like nerve damage and low blood cell counts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2009
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (immunohistochemistry \[IHC\] 0-1+ or fluorescence in situ hybridization \[FISH\]-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 (adriamycin-cytoxan \[AC\], 5-fluorouracil/adriamycin/intravenous \[IV\] cyclophosphamide \[FAC\], fluorouracil-epirubicin-IV cytoxan \[FEC\]) 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. * Patients with bilateral breast cancers are eligible. * Patients should have a Karnofsky performance scale of \>= 70%. * Peripheral granulocyte count of \>= 1500/mm\^3. * Platelet count \>= 100000 mm\^3. * Bilirubin within normal laboratory values. * Alkaline phosphatase may be up to 1.5 x upper limit of normal (ULN) of the institution. * Transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) may be up to 1.5 x upper limit of normal (ULN) of the institution. * 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. Women of childbearing potential (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 residual cancer burden (RCB) and be used for correlative studies. * Sexually active women of childbearing potential must use an effective method of birth control during the course of 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 principal investigator (PI) will immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study. Exclusion Criteria: * 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 gastrointestinal \[GI\] tract ulceration). * Patients with a pre-existing peripheral neuropathy \> grade 1. * Evidence of distant metastases.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
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Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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