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Chemotherapy

SDX-7320 + Eribulin for Breast Cancer

Q: How many people are included in this medication research study?

Yes, this is an ongoing recruitment effort that was begun on October 3rd, 20202. The information hosted on clinicaltrials.gov has been updated as recently as October 4th, 20202. In total, the researchers are looking to enroll 55 patients from 7 different trial sites.

Q: Are there different facilities across the U.S. where this research is being conducted?

Right now, this trial is being conducted at 7 sites. They are located in Middletown and Commack, Harrison, as well as other cities. If you want to reduce the amount of travel required, it would be best to select a location near you.

Q: What are the risks associated with taking SDX-7320 plus Eribulin?

The safety of SDX-7320 in conjunction with Eribulin has been supported by some data, but not enough to move beyond a Phase 2 rating.

Q: Are investigators still looking for participants for this experiment?

According to the latest update on clinicaltrials.gov, this research is looking for patients as of 10/4/2022. The study was first posted on the site on 10/3/2022.

Phase 2

Recruiting

Led By Neil Iyengar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of metabolic dysfunction defined as HbA1c > 5.5 and/or BMI ≥ 30 kg/m^2

Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether adding SDX-7320 to standard chemotherapy eribulin helps people with TNBC and metabolic dysfunction, and whether it is safe.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to SDX-7320 or eribulin such as fatigue, nausea, hair loss from chemotherapy, allergic reactions to medication components, potential blood disorders due to bone marrow suppression by chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My HbA1c is above 5.5 or my BMI is 30 or more.

Select...

I've had anthracycline and taxane chemotherapy and can be treated with eribulin.

Select...

I am fully active or can carry out light work.

Select...

My blood tests show my organs and bone marrow are working well.

Select...

I have triple-negative metastatic breast cancer that is not responsive to hormones or HER2 treatments.

Select...

My cancer is advanced or has spread, and I've had up to 2 treatments for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in insulin resistance scores (HOMA-IR)

Secondary outcome measures

Overall response rate

Therapeutic procedure

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SDX-7320 plus Eribulin (safety run-in period)Experimental Treatment2 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 EribulinExperimental Treatment2 Interventions

Patients randomized to SDX-7320 plus Eribulin.

Group III: Eribulin Plus PlaceboPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

2012

Completed Phase 3

~2700

SDX-7320

2016

Completed Phase 1

~40

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

SynDevRx, Inc.Industry Sponsor

2 Previous Clinical Trials

84 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,834 Total Patients Enrolled

202 Trials studying Breast Cancer

81,048 Patients Enrolled for Breast Cancer

Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

5 Previous Clinical Trials

388 Total Patients Enrolled

3 Trials studying Breast Cancer

260 Patients Enrolled for Breast Cancer

Media Library

Eribulin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05570253 — Phase 2

Breast Cancer Research Study Groups: Eribulin Plus Placebo, SDX-7320 plus Eribulin, SDX-7320 plus Eribulin (safety run-in period)

Breast Cancer Clinical Trial 2023: Eribulin Highlights & Side Effects. Trial Name: NCT05570253 — Phase 2

Eribulin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570253 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in this medication research study?

"Yes, this is an ongoing recruitment effort that was begun on October 3rd, 20202. The information hosted on clinicaltrials.gov has been updated as recently as October 4th, 20202. In total, the researchers are looking to enroll 55 patients from 7 different trial sites."

Answered by AI

Are there different facilities across the U.S. where this research is being conducted?

"Right now, this trial is being conducted at 7 sites. They are located in Middletown and Commack, Harrison, as well as other cities. If you want to reduce the amount of travel required, it would be best to select a location near you."

Answered by AI

What are the risks associated with taking SDX-7320 plus Eribulin?

"The safety of SDX-7320 in conjunction with Eribulin has been supported by some data, but not enough to move beyond a Phase 2 rating."

Answered by AI

Are investigators still looking for participants for this experiment?

"According to the latest update on clinicaltrials.gov, this research is looking for patients as of 10/4/2022. The study was first posted on the site on 10/3/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer

2022. "A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570253.

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