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Hormone Therapy
Samuraciclib + Fulvestrant for Breast Cancer (SUMIT-BC Trial)
Phase 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 mutation status.
Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 days 8 and 15; day 1 of cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days)
Awards & highlights
SUMIT-BC Trial Summary
This trial will test how well a new drug, samuraciclib, works with an existing one to treat breast cancer.
Who is the study for?
Adults with HR-positive, HER2-negative advanced or metastatic breast cancer who've had prior AI and CDK4/6i therapy can join. They must have measurable disease, be in fairly good health (ECOG ≤1), not severely ill from other causes, and expected to live more than 12 weeks. Pre/peri-menopausal participants should be on LHRH agonists for at least 4 weeks.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Samuraciclib combined with Fulvestrant versus just Fulvestrant alone in treating certain advanced breast cancers. It aims to see if adding Samuraciclib helps patients better than the standard treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer treatments like these may include nausea, fatigue, hormonal changes, possible liver issues, and reactions at injection sites.
SUMIT-BC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I know my TP53 mutation status.
Select...
My breast cancer is ER-positive and HER2-negative, and it has spread.
Select...
My last cancer treatment was with AI and a CDK4/6 inhibitor.
SUMIT-BC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 days 8 and 15; day 1 of cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 days 8 and 15; day 1 of cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (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
Clinical Benefit Response (CBR)
Secondary outcome measures
Duration of Response (DOR)
Fulvestrant plasma exposure: Ctrough
Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
+4 moreSUMIT-BC Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment1 Intervention
Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
Group II: Arm BExperimental Treatment2 Interventions
Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Group III: Arm AExperimental Treatment2 Interventions
Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Carrick Therapeutics LimitedLead Sponsor
3 Previous Clinical Trials
239 Total Patients Enrolled
2 Trials studying Breast Cancer
115 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,922 Total Patients Enrolled
111 Trials studying Breast Cancer
36,384 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had more than one hormone therapy for my advanced cancer.I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.My liver, kidneys, and bone marrow are not working well.I have had cancer spread to my brain or its coverings.My cancer worsened during or within 6 months after my last treatment.Participants must have a way to measure their disease, like a tumor or bone disease, according to specific guidelines.I know my TP53 mutation status.I have a serious heart condition.My breast cancer is ER-positive and HER2-negative, and it has spread.My condition is inflammatory breast cancer.My last cancer treatment was with AI and a CDK4/6 inhibitor.I started treatment with an LHRH agonist at least 4 weeks ago.I can perform light activities without assistance and my condition hasn't worsened in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm C
- Group 3: Arm A
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.
What is the size of the participant pool in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical trial which was initialised on July 31st 2023 is actively recruiting participants. 60 patients are needed from a single site for the study's successful completion."
Answered by AI
Has Arm A earned endorsement from the FDA?
"As this is a Phase 2 trial, with some evidence of safety but none for efficacy, we have assigned Arm A a score of 2 on our risk assessment scale."
Answered by AI
Is this research initiative accessible to participants at the present moment?
"From the clinicaltrials.gov records, this medical trial is presently recruiting participants. It first appeared on July 31st 2023 and was updated lastly on July 19th of that same year."
Answered by AI
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