Sacituzumab Tirumotecan for Breast Cancer

(BERLIN Trial)

LK
Overseen ByLaura Kane
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of sacituzumab tirumotecan, a new treatment for people with triple-negative breast cancer that has spread to the brain. This type of breast cancer lacks the three common receptors that typically fuel its growth. The trial aims to determine if this drug can help manage or slow cancer progression in these patients. It may suit those diagnosed with this specific breast cancer type and have brain metastases that are untreated or worsening after previous treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering hope for managing this challenging condition.

Do I need to stop my current medications for the trial?

The trial requires a washout period (time without taking certain medications) for some treatments before starting. For example, you need to stop strong CYP3A4 inducers/inhibitors 2 weeks before the trial. It's best to discuss your specific medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that sacituzumab tirumotecan is likely to be safe for humans?

Research has shown that sacituzumab tirumotecan generally presents manageable side effects for patients. In some studies, 57.7% to 63.4% of patients experienced serious side effects. The most common serious side effects include low levels of certain blood cells, which help fight infections and carry oxygen. Less serious side effects, such as nausea and hair loss, are also common but usually mild. Despite these risks, the treatment has demonstrated promising results in controlling cancer growth, especially when compared to traditional chemotherapy.12345

Why do researchers think this study treatment might be promising for breast cancer?

Sacituzumab tirumotecan is unique because it combines an antibody with a potent chemotherapy agent, specifically targeting cancer cells in breast cancer. Unlike standard treatments like hormone therapy or traditional chemotherapy, this drug delivers chemotherapy directly to the cancer cells, minimizing damage to healthy cells. Researchers are excited about its potential to improve effectiveness and reduce side effects compared to conventional treatments.

What evidence suggests that sacituzumab tirumotecan might be an effective treatment for breast cancer?

Research has shown that sacituzumab tirumotecan, the treatment under study in this trial, holds promise for treating advanced triple-negative breast cancer that has spread (mTNBC). Studies have found that this treatment helps patients live longer without their cancer worsening. Specifically, earlier research indicated that patients lived longer on average compared to those receiving traditional chemotherapy. The treatment also demonstrated a higher success rate in shrinking tumors compared to standard options. This evidence suggests that sacituzumab tirumotecan could be an effective choice for people with advanced mTNBC.24678

Who Is on the Research Team?

AK

Adriana Kahn, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with metastatic triple-negative breast cancer that has spread to the brain and can be measured on scans. Participants must have good organ function, a life expectancy of at least three months, and no severe infections or other active cancers. Pregnant or breastfeeding women cannot join.

Inclusion Criteria

I am at least 18 years old.
I do not have leptomeningeal disease.
I can have had any number of previous cancer treatments.
See 14 more

Exclusion Criteria

I need to take high doses of steroids or immune-suppressing drugs.
I have another cancer that is currently getting worse.
I currently have an infection that needs prescription medication.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan 4 mg/kg IV on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death

Up to 1 year
Visits on Day 1 and Day 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Every 12 weeks

Safety Follow-up

Safety follow-up visit occurs 30 days after the last dose to monitor adverse events

What Are the Treatments Tested in This Trial?

Interventions

  • Sacituzumab tirumotecan

Trial Overview

The study tests sacituzumab tirumotecan given by IV infusion twice in each 28-day cycle for people with TNBC brain metastases. All participants receive the same treatment until their disease worsens or side effects become too severe.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sacituzumab tirumotecanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Translational Breast Cancer Research Consortium

Collaborator

Trials
27
Recruited
3,100+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40217078/

Sacituzumab tirumotecan in previously treated metastatic ...

Sac-TMT demonstrated statistically significant and clinically meaningful improvements in PFS compared to chemotherapy, with a manageable safety ...

Initial results from the phase II OptiTROP-Breast05 study.

The median follow-up was 18.6 mo. The objective response rate (ORR) was 70.7% (29/41, 3 unconfirmed PR) and the disease control rate (DCR) was ...

Sac-TMT Improves PFS in HR+/HER2– Metastatic Breast ...

Sacituzumab tirumotecan significantly improves progression-free survival in HR+/HER2– breast cancer compared with traditional chemotherapy.

Sacituzumab tirumotecan improves OS in mTNBC

Moreover, sac-TMT significantly improved overall survival (OS) (median not reached versus 9.4 months; HR 0.53, 95% CI 0.36–0.78; P = 0.0005).

Bayesian Indirect Comparison and Cost-Effectiveness of ...

The cost-effectiveness of sacituzumab govitecan versus sacituzumab tirumotecan in metastatic triple-negative breast cancer remains unclear ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41726150/

Sacituzumab tirumotecan (sac-TMT/MK-2870/SKB264)

The safety profile of sac-TMT seems easily manageable; adverse ... data regarding its use in breast cancer. Keywords: antibody drug ...

Sacituzumab tirumotecan (sac-TMT/MK-2870/SKB264)

The safety profile of sac-TMT seems easily manageable; adverse events include mainly grade 1/2 nausea and alopecia, while grade 3/4 neutropenia and leukopenia ...

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, ...

Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting ...