← Back to Search

Hormone Therapy

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

Phase 2

Waitlist Available

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.

Must not have

More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.

Inadequate hepatic, renal, and bone marrow function.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had more than one hormone therapy for my advanced cancer.

Select...

My liver, kidneys, and bone marrow are not working well.

Select...

I have had cancer spread to my brain or its coverings.

Select...

I have a serious heart condition.

Select...

My condition is inflammatory breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Response (CBR)

Secondary study objectives

Duration of Response (DOR)

Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Objective Response Rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3520

0 / 8Eligibility criteria met