SDX-7320 + Eribulin for Breast Cancer

Recruiting at 9 trial locations

Overseen By Neil Iyengar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antihyperglycemics, QT-prolonging drugs

Disqualifiers: Diabetes, CNS pathology, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

55 Participants Needed

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot take medications that prolong the QT interval or induce Torsade de Pointes, and you must stop these 7 days before starting the trial. Herbal preparations are also not allowed, except for cannabinoids and CBD compounds.

What data supports the idea that SDX-7320 + Eribulin for Breast Cancer is an effective drug?

The available research shows that Eribulin, when used for breast cancer, has been associated with increased survival in patients who have already tried other treatments. In a key study, patients taking Eribulin lived about 13.2 months on average, compared to 10.6 months for those who did not take it. This suggests that Eribulin can help patients live longer. However, there is no specific data provided about the combination of SDX-7320 and Eribulin, so we can't say for sure how effective the combination is based on the information available. ^{1 2 3 4 5}

What safety data is available for the treatment with SDX-7320 and Eribulin for breast cancer?

Eribulin, marketed as Halaven, has been approved for use in patients with locally advanced or metastatic breast cancer who have undergone at least two prior chemotherapy regimens. The European Medicines Agency and the U.S. FDA have reviewed its safety and efficacy. Common side effects include asthenia or fatigue and neutropenia. Eribulin has been studied in various clinical trials, including phase II and III trials, showing increased overall survival in patients. However, specific safety data for the combination of SDX-7320 and Eribulin is not detailed in the provided research. ^{2 6 7 8 9}

Is the drug Eribulin a promising treatment for breast cancer?

Yes, Eribulin is a promising drug for breast cancer. It has been shown to increase overall survival in patients with advanced breast cancer who have already tried other treatments. It works by stopping cancer cells from dividing, which can lead to their death. This makes it a valuable option for patients with metastatic breast cancer. ^{1 2 7 8 10}

Research Team

Neil Iyengar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with triple-negative metastatic breast cancer who have metabolic dysfunction (HbA1c > 5.5 or BMI ≥ 30), previously treated with anthracycline and taxane, and suitable for eribulin therapy. Participants must not have had more than two prior therapies for advanced cancer, no severe heart issues, uncontrolled HIV, known allergies to the drugs tested, underweight conditions (BMI < 18.5), brain malignancies or active CNS pathology.

Inclusion Criteria

I am willing and able to follow the study's requirements, including fasting before treatment.

My cancer can be measured by scans or I have a specific type of bone lesion.

If sexually active female of childbearing potential, willing to use a contraception method listed

Exclusion Criteria

My liver disease is moderately to severely advanced.

Any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study

I have type 1 diabetes or type 2 diabetes that requires insulin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

The first 15 patients enrolled will receive SDX-7320 in combination with eribulin to confirm safety

4-6 weeks

Treatment

Participants receive either SDX-7320 plus eribulin or placebo plus eribulin

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Eribulin
• Placebo
• SDX-7320

Trial Overview The study tests SDX-7320 combined with standard chemotherapy drug eribulin against eribulin alone in treating breast cancer patients with metabolic dysfunction. The goal is to assess effectiveness and safety of this combination treatment compared to the standard therapy.

Participant Groups

Group I: SDX-7320 plus Eribulin (safety run-in period) Experimental Treatment 2 Interventions

During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized.

Group II: SDX-7320 plus Eribulin Experimental Treatment 2 Interventions

Patients randomized to SDX-7320 plus Eribulin.

Group III: Eribulin Plus Placebo Placebo Group 2 Interventions

Patients randomized to the control arm will receive placebo plus Eribulin.

Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Halaven for:

• Locally advanced or metastatic breast cancer

Approved in United States as Halaven for:

• Metastatic breast cancer
• Liposarcoma

Approved in Japan as Halaven for:

• Breast cancer
• Soft tissue sarcoma

Approved in Canada as Halaven for:

• Metastatic breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

SynDevRx, Inc.

Industry Sponsor

Trials

3

Recruited

140+

Findings from Research

In a study of 48 patients with metastatic breast cancer treated with eribulin, the drug was found to be safe and well tolerated, with no hypersensitivity reactions or toxic deaths reported.

Approximately 48% of patients experienced a clinical benefit, with one patient achieving complete remission and 33.3% showing a partial response, indicating that eribulin can be effective even in heavily pretreated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective safety and efficacy analysis of the first patients treated with eribulin for metastatic breast cancer in Stockholm, Sweden. Kessler, L., Falato, C., Margolin, S., et al.[2022]

Eribulin, a microtubule dynamics inhibitor, has been approved for treating locally advanced or metastatic breast cancer in patients who have already undergone at least two chemotherapy regimens, showing a median overall survival increase from 10.6 months to 13.2 months compared to control.

The recommended dosing regimen for eribulin is 1.23 mg/m² administered intravenously on days 1 and 8 of a 3-week cycle, with common side effects including fatigue and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. Pean, E., Klaar, S., Berglund, EG., et al.[2016]

Eribulin is an effective treatment for patients with advanced or metastatic breast cancer who have previously been treated with anthracyclines and taxanes, as shown by analyses from large Phase III clinical trials.

The drug works through both mitotic and nonmitotic mechanisms, and ongoing studies are exploring its use in combination with immunotherapies, which could enhance treatment options for aggressive breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the mechanism of action and clinical application of eribulin for metastatic breast cancer. O'Shaughnessy, J., Kaklamani, V., Kalinsky, K.[2019]

Eribulin mesylate is an effective treatment for metastatic breast cancer in patients who have already undergone at least two prior chemotherapy regimens, showing significant improvements in overall and progression-free survival in Phase III clinical trials.

This novel synthetic agent works by binding to the microtubule cap and inhibiting tubulin polymerization, leading to microtubule arrest, and has a manageable safety profile with low rates of peripheral neuropathy, primarily causing neutropenia and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eribulin mesylate: a novel halichondrin B analogue for the treatment of metastatic breast cancer. McBride, A., Butler, SK.[2022]

The combination of eribulin and S-1 was evaluated in 12 metastatic breast cancer patients, with the recommended dose for phase II trials set at eribulin 1.4 mg/m² and S-1 65 mg/m², after observing dose-limiting toxicity at higher doses.

Preliminary results showed that 41.7% of patients with measurable disease experienced a partial response, indicating potential anticancer activity that merits further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I dose-escalation study of eribulin and S-1 for metastatic breast cancer. Sakiyama, T., Tsurutani, J., Iwasa, T., et al.[2018]

Eribulin mesylate (ERI) demonstrated statistically longer overall survival compared to treatment by physician's choice and a combination of gemcitabine and vinorelbine in patients with metastatic breast cancer, based on a network meta-analysis of seven trials.

In patients with triple negative breast cancer, ERI also showed a significant overall survival benefit compared to capecitabine, highlighting its potential as an effective treatment option in this specific subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancer. Zhao, Q., Hughes, R., Neupane, B., et al.[2021]

Eribulin, a synthetic analog of the tubulin inhibitor halichondrin B, is being developed by Eisai Co Ltd as a potential cancer treatment, currently undergoing Phase III trials for breast cancer in the US and Europe.

In addition to breast cancer, eribulin is also in various stages of clinical trials for multiple other cancers, including non-small cell lung cancer (NSCLC) and soft tissue sarcoma, indicating its broad potential application in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eribulin, a simplified ketone analog of the tubulin inhibitor halichondrin B, for the potential treatment of cancer. Newman, S.[2019]

In a phase II study involving 103 heavily pretreated metastatic breast cancer patients, eribulin mesylate showed an objective response rate of 11.5% and a clinical benefit rate of 17.2%, indicating its efficacy in this challenging population.

Eribulin was generally well-tolerated, with manageable side effects; the most common severe toxicities included neutropenia (64%) and leukopenia (18%), but there were infrequent cases of neuropathy, suggesting a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. Vahdat, LT., Pruitt, B., Fabian, CJ., et al.[2022]

Eribulin demonstrates broad-spectrum antitumor activity against various human cancer types in preclinical models, showing significant tumor growth inhibition and even regression in some cases.

The study suggests that moderately intermittent dosing schedules (like the approved clinical schedule of days 1 and 8 of a 21-day cycle) provide optimal effectiveness and tolerability for eribulin treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broad spectrum preclinical antitumor activity of eribulin (Halaven(R)): optimal effectiveness under intermittent dosing conditions. Towle, MJ., Nomoto, K., Asano, M., et al.[2016]

Eribulin is an effective treatment option for patients with metastatic breast cancer who have not responded to other chemotherapy drugs, such as anthracyclines and taxanes, as it induces cancer cell death by disrupting microtubule growth.

While eribulin can be life-saving, it is associated with side effects like neutropenia, neuropathy, and QT prolongation, and ongoing trials are exploring its efficacy in other types of cancers, indicating its potential for broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eribulin drug review. Shetty, N., Gupta, S.[2022]

References

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

A retrospective safety and efficacy analysis of the first patients treated with eribulin for metastatic breast cancer in Stockholm, Sweden. [2022]

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

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Perspectives on the mechanism of action and clinical application of eribulin for metastatic breast cancer. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Eribulin mesylate: a novel halichondrin B analogue for the treatment of metastatic breast cancer. [2022]

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

A phase I dose-escalation study of eribulin and S-1 for metastatic breast cancer. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancer. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Eribulin, a simplified ketone analog of the tubulin inhibitor halichondrin B, for the potential treatment of cancer. [2019]

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

Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. [2022]

9. Greece pubmed.ncbi.nlm.nih.gov

Broad spectrum preclinical antitumor activity of eribulin (Halaven(R)): optimal effectiveness under intermittent dosing conditions. [2016]

10. India pubmed.ncbi.nlm.nih.gov

Eribulin drug review. [2022]