Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
Male or Female >18 years of age on the day of informed consent signing.
Progression on a CDK4/6 inhibitor in combination with an AI immediately prior to the enrollment on this study
IHC 1+ or 0
Single-probe average HER2 copy number <4.0 signals/cell
Disqualifiers
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration.
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent. Note: If the patient received major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the trial treatment.
The patient has had major surgery within 14 days prior to starting the study.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Trial design
Treatments tested in this trial
- Fulvestrant Run-In
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
The Methodist Hospital Research Institute
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov