Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT05305924
Phase
PHASE2
Status
Recruiting
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Conditions

  • ER-Positive Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Fulvestrant Run-In — DRUG
    The study is evaluating if a drug holiday (post CDK inhibitors progression) will reset the cell cycle machinery to be responsive to Abemaciclib and Fulvestrant.

Study Details

The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.

Key Dates

Start date
Feb 25, 2021
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-In
    A 1-month (28 days) run-in of fulvestrant will precede fulvestrant plus abemaciclib treatment. Fulvestrant at a dose of 500 mg will be administered intramuscularly (IM) into the buttocks slowly (1-2 minutes per injection) as two 5-mL injections, one in each buttock, on Days 1 and 15 of the run-in period. After the fulvestrant run-in, fulvestrant plus abemaciclib will be administered in 28-day cycles until disease progression or unacceptable toxicity. Fulvestrant (500 mg IM) will be administered on Day 1 of each 28-day cycle. Abemaciclib at a dose of 150 mg will be given p.o. BID on Days 1-28 of each cycle

Primary Outcome Measure

Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant [ Time Frame: TTF will be defined as time from start of therapy to discontinuation for any cause. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Cancer CenterHoustonTexas77030
Polly Niravath, MD
[email protected]
713-441-0629

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By research site
Houston Methodist Cancer Center· Houston, TX

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