Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04923542
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • HR+ Metastatic Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Radiosurgery (SRS) — RADIATION
    Patients will receive single session SRS to intact brain metastases and post-operative cavities. For intact brain metastases, this will be 15 Gy to lesions between 31-40 mm, 18 Gy to 21- 30 mm, and 24 Gy to lesions measuring ≤ 20 mm.
  • Abemaciclib — DRUG
    Abemaciclib is an orally administered selective small-molecule inhibitor of CDK4 and CDK6 that is 14 times more potent against CDK4 than CDK6 in enzymatic assays that is approved for the treatment of advanced or metastatic breast cancers. Abemaciclib will be administered at a dose of 150 mg twice daily.
  • Endocrine therapy — DRUG
    Abemaciclib will be administered with standard of care endocrine therapy. Endocrine therapy can consist of fulvestrant or an aromatase inhibitor. Dosing of concurrent endocrine therapy with abemaciclib should follow standard dosing and safety guidelines.

Study Details

This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.

Key Dates

Start date
Nov 30, 2021
Status verified
Feb 2026
Primary completion
Nov 5, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
31 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Radiation Therapy and Abemaciclib
    Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib. In the phase I portion, safety will be monitored initially by a 3+3 design. If unexpected neurologic toxicities are noted, the dose of radiation therapy will be modified.
  • Experimental: Phase 2: Radiation Therapy and Abemaciclib
    Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation at the phase 1 dose to sites of brain metastases or post-operative cavities with continued abemaciclib.

Primary Outcome Measure

Intracranial Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sasha Beyer, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLOhio State University Comprehensive Cancer Center· Columbus, OH

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