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CDK4/6 Inhibitor
Endocrine Therapy + Abemaciclib for Breast Cancer
Phase 2
Waitlist Available
Led By Sarah Sammons, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a new cancer drug on the tumor and the patient's immune system.
Who is the study for?
This trial is for women over 18 with advanced ER+/HER2- breast cancer who can swallow pills, have good organ function, and can undergo biopsies. They should not be using hormonal birth control or have active cancers (except certain skin cancers), autoimmune diseases, serious infections, or conditions that make biopsy unsafe.
What is being tested?
The study tests how standard endocrine therapy plus abemaciclib affects immune cells in the tumor environment of breast cancer patients. It involves detailed analysis through single cell RNA sequencing and monitoring changes related to serum estrogen levels.
What are the potential side effects?
Potential side effects include reactions from biopsies, fatigue from treatment, possible digestive issues due to oral medications, and risks associated with changes in immune cell functions which could affect overall immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in serum estrogen (E1 and E2) levels compared to changes in tumor immune cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition
Changes in serum estrogen (E1 and E2) levels compared to peripheral blood mononuclear cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition
Secondary study objectives
Best overall response rate of abemaciclib and endocrine therapy in both treatment arms
Changes in tumor immune cell populations in response to fulvestrant and aromatase inhibitor therapy plus abemaciclib, measured by sequential biopsies
Biopsy
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Cohort 1Active Control2 Interventions
Fulvestrant plus abemaciclib
Group II: Cohort 2Active Control2 Interventions
Aromatase inhibitor plus abemaciclib (with or without ovarian suppression)
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
2,971,741 Total Patients Enrolled
55 Trials studying Breast Cancer
9,445 Patients Enrolled for Breast Cancer
Sarah Sammons, MDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
220 Total Patients Enrolled
2 Trials studying Breast Cancer
126 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I do not have serious health issues that would stop me from joining this study.I am on blood thinners due to a history of blood clots or heart conditions.I have a tumor from breast cancer that can be biopsied.I have fully recovered from any side effects of my recent radiotherapy.I have a bleeding disorder that makes biopsies unsafe for me.My breast cancer is estrogen receptor positive.I am starting standard hormone therapy for my condition.My cancer is not HER2 positive.I can take pills by mouth.My condition cannot be checked with a biopsy.I've had a severe allergic reaction to the numbing medicine used in a biopsy.I haven't taken steroids or immunosuppressants in the last 30 days.I have not had any cancer except for skin cancer in the last 5 years.I am currently using hormonal birth control or estrogen replacement therapy.I have not taken medication for an autoimmune disease in the last 6 months.I am not using cancer treatments other than bisphosphonates.I am not pregnant or breastfeeding.I do not have any active infections.My breast cancer cannot be removed by surgery or has spread.I am willing and able to have biopsies before and 4 weeks into treatment.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am a woman aged 18 or older.I have recovered from the side effects of my last chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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