Ixabepilone for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called ixabepilone to evaluate its effectiveness for individuals with a specific type of breast cancer lacking the HER2 protein. Ixabepilone aims to stop cancer cells from dividing, potentially killing them. Participants will receive either this experimental treatment or standard care for comparison. The trial seeks participants who have completed certain chemotherapy treatments but still have noticeable cancer. It is suitable for those with HER2-negative breast cancer who have experienced disease progression after initial therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ixabepilone has been studied in breast cancer patients and has demonstrated some positive effects. In one study of 34 patients with advanced breast cancer, 28% experienced a reduction in tumor size. However, safety is also a crucial consideration. Studies have found that while ixabepilone can be effective, it may cause side effects such as tiredness, low blood cell counts, and nerve issues.

Patients have reported varying experiences with ixabepilone. Some managed the side effects well, while others faced more challenges. Prospective trial participants should weigh the potential benefits against these risks. Consulting a healthcare provider is essential to determine if this is the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Ixabepilone is unique because it belongs to a class of drugs known as epothilones, which work by disrupting the microtubules inside cancer cells, effectively stopping them from dividing and growing. Unlike traditional chemotherapies such as anthracyclines or taxanes, which are commonly used in breast cancer treatment, ixabepilone can overcome resistance that some tumors develop against these standard treatments. Researchers are excited about ixabepilone because of its potential to be effective in patients whose cancers are no longer responding to other therapies, offering a new hope for those with limited options.

What evidence suggests that ixabepilone might be an effective treatment for breast cancer?

Research has shown that ixabepilone, which participants in this trial may receive, can help treat breast cancer. In some studies, 28–32% of patients who received ixabepilone experienced tumor shrinkage or disappearance. On average, patients went about 4 months without cancer progression, known as progression-free survival. Some patients with triple-negative breast cancer, a challenging type to treat, had similar outcomes. Overall, ixabepilone shows promise, especially when used earlier in treatment plans. Participants in another arm of this trial will receive the standard of care for comparison. ^{1 2 3 4 6}

Who Is on the Research Team?

Funda Meric-Bernstam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8290913/

Ixabepilone: Overview of Effectiveness, Safety, and ... Early evidence of antitumor activity in a range of xenograft models has supported the study of ixabepilone in breast cancer as well as in ovarian cancer (18).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11596583/

Evaluation of ixabepilone efficacy and tolerability in ... In our study, we showed that ixabepilone treatment has a statistically significant positive effect on survival if preferred in earlier metastatic lines.

3. journalofoncology.org journalofoncology.org/articles/ixabepilone-in-metastatic-breast-cancer-real-world-experience/jos.2021-81340

Ixabepilone in Metastatic Breast Cancer: Real-World ... The median use of ixabepilone was the sixth line. The objective response rate was 32%. Patients had a median progression-free survival (PFS) of 4 months, and ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.e13067

Ixabepilone efficacy and tolerability in metastatic breast ... Overall survival (OS) was 11.3 months. A subset of patients that had triple negative breast cancer (N = 37) had similar PFS, 3.6 months, and OS, ...

5. journalofoncology.org journalofoncology.org/articles/efficacy-and-safety-of-ixabepilone-in-metastatic-breast-cancer-after-multiple-treatments-analysis-based-on-real-world-data/doi/jos.2024-102164

Efficacy and Safety of Ixabepilone in Metastatic Breast ... Results: The analysis of 34 patients revealed a median OS of 10.0 months, a median PFS of 4.2 months, and an objective response rate (ORR) of 28%.The patients ...

6. jppres.com jppres.com/jppres/pdf/vol12/jppres23.1869_12.4.722.pdf

Systematic review on the efficacy and safety of ixabepilone ... Ixabepilone addition to capecitabine significantly prolonged progression-free survival and objective response rate in TNBC patients, but did not ...