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CDK4 and CDK6 inhibitor
High-Dose Abemaciclib for Early-Stage Breast Cancer
Phase 2
Recruiting
Led By Erica Mayer, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 14 days must have elapsed between end of radiotherapy and day 1 of treatment with abemaciclib. Participants who received prior radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. No radiotherapy should be planned to occur during study therapy
Women of child-bearing potential and men with partners of childbearing potential must be willing to employ one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 3 months after the last dose of abemaciclib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing if a higher dose of abemaciclib is better tolerated than the standard dose for treating early-stage breast cancer.
Who is the study for?
This trial is for men and women over 18 with high-risk hormone receptor positive, HER2- early-stage breast cancer. They must have completed surgery within the last 16 months, may already be on endocrine therapy, and should not have had chemotherapy or radiotherapy recently. Participants need to use effective nonhormonal contraception and cannot be pregnant or nursing.Check my eligibility
What is being tested?
The TRADE study is testing a new way of giving abemaciclib where doses increase over time. This approach aims to see if it's easier for patients to handle than the standard dose. The trial includes other drugs like Tamoxifen and aromatase inhibitors that are commonly used in breast cancer treatment.See study design
What are the potential side effects?
Abemaciclib can cause diarrhea, fatigue, low blood cell counts increasing infection risk, liver problems, deep vein thrombosis (blood clots), pulmonary embolism (clot in lung), and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.
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I am using reliable birth control methods during and 3 months after the study.
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It's been over 3 weeks since my last chemotherapy, and I've recovered from its side effects.
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My breast cancer is stage II or III, affects lymph nodes, is hormone receptor positive and HER2 negative.
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I am fully active or can carry out light work.
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My blood counts and liver function tests are within the required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Adverse Rate at 3 months
Secondary outcome measures
Composite Rate of Abemaciclib
Dose Intensity of Abemaciclib
Incidence of Grade 2-4 Diarrhea
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AbemaciclibExperimental Treatment6 Interventions
Study procedures will be conducted as follows:
Cycles 1 - 24
Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day.
Endocrine therapy 1 x per day.
In clinic visits with blood tests, questionnaires, and assessments:
Day 1 of Cycles 1, 2, and 3
Day 15 of Cycles 1 and 2
Every three cycles after Cycle 3 Day 1.
End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
2005
Completed Phase 4
~30070
Abemaciclib
2019
Completed Phase 2
~1710
Exemestane
2003
Completed Phase 4
~7880
LHRH Agonist
2013
Completed Phase 2
~130
Anastrozole
2019
Completed Phase 4
~10300
Letrozole
2002
Completed Phase 4
~3240
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,887 Total Patients Enrolled
141 Trials studying Breast Cancer
22,527 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,509 Total Patients Enrolled
63 Trials studying Breast Cancer
36,814 Patients Enrolled for Breast Cancer
Erica Mayer, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
270 Total Patients Enrolled
2 Trials studying Breast Cancer
245 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are presently conducting this research initiative?
"This clinical trial has 8 locations, including Dana-Farber Cancer Institute in Brighton, Dana-Farber Cancer Institute at Steward St. Elizabeth's in Foxboro, and Dana-Farber Cancer Institute at Foxborough in Methuen along with 5 other sites."
Answered by AI
Are there any openings available for participants in this experimental trial?
"Presently, this particular trial is not seeking participants. It was posted on February 1st of 2024 and last updated on August 14th 2023. However, alternative trials are actively enrolling patients; with 2667 different opportunities currently available."
Answered by AI
What adverse effects are associated with Abemaciclib consumption?
"Abemaciclib's safety score is a 2, since there exists existing clinical data regarding its safety but no proof of effectiveness."
Answered by AI
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