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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fulvestrant Run-In
DrugThe study is evaluating if a drug holiday (post CDK inhibitors progression) will reset the cell cycle machinery to be responsive to Abemaciclib and Fulvestrant.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-InExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant
Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame
TTF will be defined as time from start of therapy to discontinuation for any cause.Secondary outcomes
1
Estimation of the CBR of fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant
Estimation of the CBR of fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI, as assessed by the RECIST 1.1.
Time frame
CBR will be defined as the percentage of patients with CR, PR, or stable disease (SD) according to the RECIST 1.1.2
PFS rate between fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant.
PFS rate between fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI.
Time frame
PFS will be defined as the date of the first dose of trial treatment to the date of progression or death due to any cause, whichever occurs first, assessed up to 12 months after the last subject is added.3
Toxicity/safety between fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant.
Toxicity/safety between fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Time frame
Toxicity will be defined as any treatment-related death or any ≥ Grade 3 AE excluding alopecia and constitutional symptoms as assessed by the NCI CTCAE v4.03 through study completion, an average of 1 year.4
Quality of life assessment after fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant.
Quality of life assessment after fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI, as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30).
Time frame
Patient-reported quality of life after fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant, as assessed by the EORTC QLQ-C30 through study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Methodist Hospital Research Institute
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov