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Hormone Therapy

Mirdametinib for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Ezra Rosen, MD, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days from first day of treatment
Awards & highlights
No Placebo-Only Group

Summary

This study is evaluating whether a drug called mirdametinib is safe for people with advanced solid tumor cancer.

Eligible Conditions
  • Breast Cancer
  • Cancer
  • MEK1 Gene Mutation
  • MEK2 Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days from first day of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days from first day of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Treatment/DLT Evaluable Population

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 2, Part 2 - mirdametinib as single agentExperimental Treatment1 Intervention
Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 2: dose expansion cohorts
Group II: Arm 2, Part 1 - mirdametinib as single agentExperimental Treatment1 Intervention
Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 1: mirdametinib dose escalation to MTD or RP2D according to the 3+3 design
Group III: Arm 1, Part 2 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions
Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 2: dose expansion cohorts where the mirdametinib RP2D will be administered in combination with the standard recommended dose of fulvestrant
Group IV: Arm 1, Part 1 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions
Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 1: safety run-in (confirmation of the RP2D for mirdametinib in combination with the standard recommended dose of fulvestrant). This part may include the mirdametinib dose de-escalation according to the 3+3 design if necessary
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirdametinib
2021
Completed Phase 2
~10
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,945 Total Patients Enrolled
206 Trials studying Breast Cancer
83,993 Patients Enrolled for Breast Cancer
Ezra Rosen, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05054374 — Phase 1 & 2
Breast Cancer Research Study Groups: Arm 1, Part 1 - mirdametinib in combination with fulvestrant, Arm 1, Part 2 - mirdametinib in combination with fulvestrant, Arm 2, Part 1 - mirdametinib as single agent, Arm 2, Part 2 - mirdametinib as single agent
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05054374 — Phase 1 & 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054374 — Phase 1 & 2
~1 spots leftby Oct 2025
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