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Can a new drug help when standard chemo leaves cancer behind?

NCT ID NCT00877500

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2009

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699, United States

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

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