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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 belowSelect...
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.
Select...
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.
Select...
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:Select...
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.
Select...
My cancer has spread to my brain, meeting specific study criteria.
Select...
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 weeks3 visits
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.
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.
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 moreSide effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850773%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood, liver, and kidney functions are all within normal ranges.You are allergic to certain medications or their ingredients.I have a bleeding disorder or am currently using blood thinners.I am using corticosteroids for brain metastases.I do not have any active infections.You currently have hepatitis B or C infection that is not under control.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.You have had specific heart or blood vessel problems in the past.My cancer can be measured by scans or is only in my bones.My cancer has spread to my brain, meeting specific study criteria.I have recovered from the immediate side effects of my cancer treatments.My breast cancer is ER-positive and HER2-negative.I can swallow pills.I have symptoms of not absorbing nutrients well.I am not taking strong drugs that affect liver enzymes.I have not received a live vaccine recently.I don't have any health issues that could affect the trial's results.I am fully active or can carry out light work.I have another cancer that is growing or needs treatment.You have reached menopause or are receiving a specific treatment that stops your ovaries from working.My cancer progressed after treatment with a CDK4/6 inhibitor and an AI.I do not have serious or uncontrolled health conditions.You are expected to live for at least 6 more months.I have had heart problems in the last year.I am a woman over 18 and have signed the consent form.Women must have a negative pregnancy test within 7 days before starting the trial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-In
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.