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SM-88 for Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Breast Cancer+2 MoreSM-88 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combo treatment for metastatic breast cancer. They want to see if it's effective and has acceptable side effects.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer
  • Hormone Receptor Positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Exercise Treatment
1
Capecitabine
1
Onapristone ER

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Year 2
Changes in cell free DNA (cfDNA)
Year 2
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Up to 2 years
Clinical Benefit Rate (CBR) at ≥ 24 weeks
Duration of Response (DOR)
Objective Response Rate (ORR)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Exercise Treatment
1
Capecitabine
1
Onapristone ER

Trial Design

1 Treatment Group

oral SM-88
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: SM-88 · No Placebo Group · Phase 2

oral SM-88
Drug
Experimental Group · 1 Intervention: SM-88 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
320 Previous Clinical Trials
120,550 Total Patients Enrolled
2 Trials studying Metastatic Breast Cancer
49 Patients Enrolled for Metastatic Breast Cancer
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
186 Total Patients Enrolled
Nadia Ashai, MDPrincipal InvestigatorGeorgetown University
Julie Collins, MD MPHPrincipal InvestigatorGeorgetown University
Candace Mainor, MDPrincipal InvestigatorGeorgetown University
2 Previous Clinical Trials
93 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received no more than 4 lines of systemic therapy for the treatment of breast cancer in the metastatic setting.
You have breast cancer with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
You have a documented ER-positive or PR-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy.
Patients with brain metastases may be treated with radiotherapy to the brain if they are asymptomatic, have not received local therapy, and are not taking steroids.
References

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