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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
Adequate organ function criteria including hematological, hepatic, and renal function
Measurable disease according to the RECIST 1.1 or bone-only disease
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
Study 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.Check my eligibility
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.See study design
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 blood, liver, and kidney functions are all within normal ranges.
Select...
My cancer can be measured by scans or is only in my bones.
Select...
I have recovered from the immediate side effects of my cancer treatments.
Select...
My breast cancer is ER-positive and HER2-negative.
Select...
I can swallow pills.
Select...
I am fully active or can carry out light work.
Select...
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant
Secondary outcome measures
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 2016 Phase 2 & 3 trial • 12 Patients • NCT0211680350%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
HYPERTRIGLYCERIDAEMIA
10%
NAUSEA
10%
PLATELET COUNT DECREASED
10%
CONTUSION
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
DYSPEPSIA
10%
DRY MOUTH
10%
PNEUMONIA
10%
HERPES ZOSTER
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant
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
271 Previous Clinical Trials
80,347 Total Patients Enrolled
13 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,030 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research project?
"Affirmative, according to the clinicaltrials.gov website this medical experiment is in need of participants. It was first published on February 25th 2021 and most recently updated on March 23rd 2022. About 56 people are required from 1 research facility for completion of the trial."
Answered by AI
Have any regulatory bodies given the green light to Fulvestrant Run-In?
"Our team at Power has assigned Fulvestrant Run-In a score of 2, as it is only backed by limited safety data and no efficacy evidence."
Answered by AI
To what extent is this trial populated by participants?
"Affirmative, according to the information found on clinicaltrials.gov this trial is actively searching for participants. It was first posted in February 2021 and most recently updated in March 2022; 56 patients are needed from one medical centre."
Answered by AI
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