Samuraciclib + Fulvestrant for Breast Cancer
(SUMIT-BC Trial)

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Carrick Therapeutics Limited

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Eligibility Criteria

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.

Inclusion Criteria

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.

Expected life expectancy of >12 weeks in the judgement of the treating investigator.

+5 more

Exclusion 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.

+4 more

Participant Groups

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.

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.

Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Faslodex for: