Ixabepilone for Breast Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Anthracyclines, Taxanes

Disqualifiers: HER2 positive, Other cancers, Uncontrolled diseases, Neuropathy, Metastases

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 18 weeks

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Ixabepilone for breast cancer?

Research shows that Ixabepilone is effective for treating metastatic breast cancer, especially in patients whose cancer has not responded to other treatments like anthracyclines and taxanes. It is approved by the FDA for this use, and studies have shown it can be effective even when other drugs have failed. ^{1 2 3 4 5}

What is known about the safety of ixabepilone in humans?

Ixabepilone has been studied for safety in patients with metastatic breast cancer and other solid tumors. It has a favorable safety profile, with side effects that are predictable and manageable through dose adjustments and treatment breaks. ^{1 2 3 6 7}

What makes the drug ixabepilone unique for treating breast cancer?

Ixabepilone is unique because it is a microtubule-stabilizing agent that works differently from other chemotherapy drugs like anthracyclines and taxanes. It is effective for patients with metastatic breast cancer who have not responded to these other treatments. ^{1 2 3 4 5}

Research Team

Funda Meric-Bernstam, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women with HER2/Neu negative invasive breast cancer who still have significant disease after systemic therapy. They must be able to use contraception, have a Karnofsky performance scale of >= 70%, normal creatinine and bilirubin levels, no history of other invasive cancers in the last 5 years (except certain skin/cervical cancers), and no severe pre-existing conditions.

Inclusion Criteria

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.

Your platelet count is at least 100,000 per cubic millimeter.

I have cancer in both breasts.

Exclusion Criteria

I have not had any cancer except for skin or cervical cancer in the last 5 years.

I do not have any severe health issues that could affect my participation in the study.

My cancer has spread to distant parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ixabepilone intravenously over 3 hours on day 1, with treatment repeating every 21 days for up to 6 courses, or receive standard of care for 18 weeks

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then every 6 months for 3 years

Treatment Details

Interventions

• Ixabepilone

Trial Overview The trial is testing Ixabepilone's effectiveness compared to standard care in treating patients with residual breast cancer post-therapy. Ixabepilone aims to block cell division, potentially leading to cancer cell death.

Participant Groups

Group I: Group I (ixabepilone) Experimental Treatment 1 Intervention

Participants receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Group II (standard of care) Active Control 1 Intervention

Participants receive standard of care for 18 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Ixabepilone is an effective treatment option for patients with metastatic breast cancer who have not responded to standard chemotherapy, showing clinical activity in those resistant to anthracyclines and taxanes, as demonstrated in Phase II trials.

In a Phase III trial, ixabepilone combined with capecitabine significantly improved objective response rates and progression-free survival compared to capecitabine alone, while being generally well tolerated with manageable side effects like myelosuppression and reversible peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixabepilone: a novel microtubule-stabilizing agent for the treatment of metastatic breast cancer. Goodin, S.[2019]

The maximum tolerated dose (MTD) of the novel oral formulation of ixabepilone was determined to be 25 mg, with common dose-limiting toxicities including neutropenia and diarrhea observed in a study involving 44 patients with advanced solid tumors.

The pharmacokinetics of oral ixabepilone showed high variability in plasma concentrations, suggesting that its safety and efficacy may be unpredictable, especially when considering factors like food intake and gastric pH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of oral ixabepilone in patients with advanced solid tumors. Deeken, JF., Marshall, JL., Pishvaian, MJ., et al.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Ixabepilone: a novel microtubule-stabilizing agent for the treatment of metastatic breast cancer. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Systematic review of ixabepilone for treating metastatic breast cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ixabepilone: a new antimitotic for the treatment of metastatic breast cancer. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Dose-dense FEC followed by dose-dense ixabepilone as neoadjuvant treatment for breast cancer patients: a feasibility study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

A phase I study of oral ixabepilone in patients with advanced solid tumors. [2014]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Ixabepilone: a new treatment option for the management of taxane-resistant metastatic breast cancer. [2021]