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Selective Estrogen Receptor Downregulator (SERD)
Samuraciclib + Elacestrant for Advanced Breast Cancer (SUMIT-ELA Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Carrick Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known TP53 and ESR1 mutation status.
Received prior AI in combination with a CDK4/6i as the last therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening
Awards & highlights
SUMIT-ELA Trial Summary
This trial tests a new med combo to treat advanced breast cancer. Safety & effectiveness will be checked.
Who is the study for?
This trial is for adults with HR+/HER2-negative advanced or metastatic breast cancer who've seen their disease progress after recent therapy. They must have had prior treatment with an AI and a CDK4/6 inhibitor, know their TP53 and ESR1 mutation status, and meet certain health criteria like good organ function and performance status.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two drugs, Samuraciclib and Elacestrant Dihydrochloride, in treating advanced breast cancer. It's an international Phase 1b/2 trial where all participants will receive both medications to see how well they work together.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer treatments may include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, hormonal changes (especially relevant for premenopausal women), as well as potential heart or kidney problems.
SUMIT-ELA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I know my TP53 and ESR1 mutation status.
Select...
My last cancer treatment was with AI and a CDK4/6 inhibitor.
Select...
My breast cancer is ER-positive and HER2-negative, and it has spread.
SUMIT-ELA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 2 and 15; day 2 of cycle 2; day 1 of cycles 3-6 and end of treatment within 28 days of last dose of imp and prior to the initiation of a new anticancer therapy (each cycle is 28 days)]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 2 and 15; day 2 of cycle 2; day 1 of cycles 3-6 and end of treatment within 28 days of last dose of imp and prior to the initiation of a new anticancer therapy (each cycle is 28 days)]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b (Dose-finding)
Phase 2 (Expansion)
Secondary outcome measures
Best percent change in tumor size.
Clinical Benefit Response (CBR)
Duration of Response (DOR)
+7 moreSUMIT-ELA Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4 ExpansionExperimental Treatment2 Interventions
Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Group II: Cohort 3Experimental Treatment2 Interventions
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Group III: Cohort 2Experimental Treatment2 Interventions
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Group IV: Cohort 1Experimental Treatment2 Interventions
Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).
Find a Location
Who is running the clinical trial?
Carrick Therapeutics LimitedLead Sponsor
3 Previous Clinical Trials
251 Total Patients Enrolled
2 Trials studying Breast Cancer
127 Patients Enrolled for Breast Cancer
Berlin-Chemie AG Menarini GroupIndustry Sponsor
2 Previous Clinical Trials
392 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I know my TP53 and ESR1 mutation status.I started treatment with an LHRH agonist at least 4 weeks ago.I have had cancer spread to my brain or its coverings.I can perform light activities without assistance and my condition hasn't worsened in the last 2 weeks.You must have a specific type of disease that can be measured using a standard method called RECIST version 1.1.My condition worsened within 6 months after my last treatment.My last cancer treatment was with AI and a CDK4/6 inhibitor.I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.My condition is inflammatory breast cancer.My liver, kidneys, and bone marrow are not working well.I have had more than one hormone therapy for my advanced cancer.I have a serious heart condition.My breast cancer is ER-positive and HER2-negative, and it has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: Cohort 2
- Group 4: Cohort 4 Expansion
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.
How many medical settings is this trial occurring across?
"This trial is running at 28 different locations, including Northwestern University in Chicago, Massachusetts General Hospital in Boston and Dana-Farber Cancer Institute EDDC in Cleveland."
Answered by AI
Are there any open positions for participants in this clinical experiment?
"The details found on clinicaltrials.gov verify that this trial is actively recruiting participants, having been first posted on July 30th 2023 and most recently updated on July 19th of the same year."
Answered by AI
What is the magnitude of individuals enrolled in this experiment?
"Correct. Clinicaltrials.gov has the latest information on this trial, which was initially posted on July 30th 2023 and last revised a few days later on the 19th of that month. The study is looking to enroll 48 patients at 28 different locations around the country."
Answered by AI
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