Actively Recruiting
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
Led by The Methodist Hospital Research Institute · Updated on 2026-01-28
28
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older at the time of consent signing
- Disease progression on a CDK4/6 inhibitor combined with an aromatase inhibitor immediately before enrollment
- Histologically confirmed ER-positive (≥1% IHC staining) and HER2-negative metastatic breast cancer
- Measurable disease by RECIST 1.1 or bone-only disease
- Postmenopausal status or receiving ovarian ablation with a GnRH agonist (started at least 2 weeks prior to treatment)
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 6 months
- Recovery from chemotherapy acute effects (CTCAE Grade ≤1) with at least 21 days washout before randomization
- Recovery from radiotherapy acute effects with at least 21 days washout before randomization
- Adequate organ function as defined by blood counts and liver and kidney function tests
- Ability to swallow oral medication
- Willingness to use contraception if made postmenopausal by GnRH agonists
- Negative serum pregnancy test within 7 days prior to treatment if applicable
- Able and willing to provide written informed consent
You will not qualify if you...
- Participation in another investigational study or receipt of investigational therapy/device within 3 weeks prior to treatment
- Chemotherapy, targeted therapy, or radiation within 2 weeks prior to treatment or not recovered from prior adverse events
- Major surgery within 14 days before starting study treatment
- Active or progressing additional malignancy requiring treatment (except certain skin cancers and in situ cervical cancer)
- Serious uncontrolled medical conditions that would interfere with study participation
- Conditions or abnormalities that may affect trial results or patient safety
- Psychiatric or substance abuse disorders that impair study cooperation
- Concurrent use of strong CYP3A inhibitors or inducers
- Known allergy to fulvestrant, abemaciclib, or their components
- Malabsorption or prior gastrointestinal surgery affecting absorption
- Bleeding disorders or current anticoagulant use
- Active hepatitis B or C infection
- Active systemic bacterial, fungal, or viral infections
- History of specific serious cardiac conditions
- Untreated or symptomatic brain metastases requiring therapy
- Live vaccination within 28 days prior to treatment
- Certain cardiovascular events within the last 12 months
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Polly Niravath, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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