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CDK4/6 Inhibitor

Fulvestrant + Abemaciclib for Breast Cancer

Phase 2
Recruiting
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease according to the RECIST 1.1 or bone-only disease
Histologically confirmed ER-positive, HER2-negative metastatic breast cancer with specific criteria for ER-positive and HER2-negative status
Must not have
Bleeding disorder or current use of anticoagulants
Corticosteroid use for brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore if taking a one-month break from CDK4/6 inhibitor drug, abemaciclib, will make the body more sensitive to the drug and improve its effectiveness when used with fulvestrant.

Who is the study for?
This trial is for postmenopausal women over 18 with ER-positive, HER2-negative metastatic breast cancer that has worsened on a CDK4/6 inhibitor and an AI. Participants must be able to take oral meds, have no severe heart conditions or mental health issues affecting participation, not be pregnant or breastfeeding, and agree to use contraception during the trial.
What is being tested?
The study tests if taking a one-month break from abemaciclib can make the body more responsive to it when used with fulvestrant afterward. Some participants will start directly on both drugs while others will have a run-in period with just fulvestrant before adding abemaciclib.
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, diarrhea, and potential allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by scans or is only in my bones.
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My breast cancer is ER-positive and HER2-negative.
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I can swallow pills.
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I am fully active or can carry out light work.
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My cancer progressed after treatment with a CDK4/6 inhibitor and an AI.
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I am a woman over 18 and have signed the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder or am currently using blood thinners.
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I am using corticosteroids for brain metastases.
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I do not have any active infections.
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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.
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My cancer has spread to my brain, meeting specific study criteria.
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I have symptoms of not absorbing nutrients well.
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I am not taking strong drugs that affect liver enzymes.
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I have not received a live vaccine recently.
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I do not have serious or uncontrolled health conditions.
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I have had heart problems in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant
Secondary study objectives
Estimation of the CBR of fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant
ORR of 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.
+2 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
73%
Palmar-plantar erythrodysesthesia syndrome
58%
Fatigue
56%
Diarrhea
38%
Hypertension
38%
Nausea
30%
Mucositis
29%
Vomiting
26%
Weight loss
26%
Weight gain
24%
Anorexia
20%
Nail disorder
17%
Back pain
16%
Hypothermia
15%
Constipation
15%
Abdominal pain
14%
Neutrophil count decreased
13%
Dizziness
13%
Upper respiratory infection
13%
Headache
11%
Dyspepsia
10%
Pain in extremity
10%
Fever
10%
Obesity
10%
Dysgeusia
9%
Bone pain
9%
Anemia
9%
Arthralgia
8%
Cough
8%
Pruritus
7%
Flu like symptoms
6%
Pain
4%
Alopecia
2%
Thromboembolic event
2%
Bone fracture
1%
Gastrointestinal infection
1%
Spinal cord compression
1%
Febrile neutropenia
1%
Respiratory infection
1%
Hot flashes
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-InExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
287 Previous Clinical Trials
81,752 Total Patients Enrolled
13 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,356 Total Patients Enrolled
65 Trials studying Breast Cancer
36,728 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05305924 — Phase 2
Breast Cancer Research Study Groups: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-In
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05305924 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305924 — Phase 2
~1 spots leftby Mar 2025