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Anti-microtubule agent

Immunotherapy for Triple-Negative Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression by local assessment)

Tumor PD-L1 expression as documented through central testing of a representative tumor tissue specimen

Must not have

Active tuberculosis (TB)

Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess a new immunotherapy for Stage IV triple-negative breast cancer, to see if it is safe and effective.

Who is the study for?

This trial is for adults with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. Participants must have no prior treatments for their condition, measurable disease per RECIST v1.1 criteria, good performance status (ECOG 0 or 1), adequate organ function, and negative tests for HIV and hepatitis. Pregnant or breastfeeding individuals are excluded.

What is being tested?

The study compares the effectiveness of a new immunotherapy drug called Tobemstomig combined with Nab-Paclitaxel versus Pembrolizumab (an existing treatment) plus Nab-Paclitaxel in treating advanced triple-negative breast cancer that expresses PD-L1.

What are the potential side effects?

Potential side effects include allergic reactions to the drugs' components, immune-related issues such as inflammation in various organs due to the immunotherapies involved, infusion reactions from the medications given through veins, and typical chemotherapy-associated effects like fatigue and digestive problems.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is advanced, cannot be surgically removed, and lacks HER2, ER, and PgR.

Select...

My tumor has been tested and shows PD-L1 expression.

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I haven't received any systemic therapy for my advanced TNBC.

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I am fully active or can carry out light work.

Select...

My cancer is classified as HER2-low.

Select...

I have been screened for hepatitis B with specific test results.

Select...

My cancer has spread and can be measured outside of the bone.

Exclusion Criteria

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

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I have active tuberculosis.

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I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.

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I have previously been treated with specific immune therapy drugs.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have high calcium levels in my blood.

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I have had a previous transplant of stem cells or an organ.

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I have a history or risk of irregular heartbeats due to heart conditions or electrolyte issues.

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I have or had an autoimmune disease or immune deficiency.

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I am allergic to ingredients in nab-paclitaxel.

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I have brain metastases that are untreated or getting worse.

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I need frequent procedures to remove fluid from my chest, heart area, or abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment2 Interventions

Participants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Group II: Arm BActive Control2 Interventions

Participants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-Paclitaxel

2014

Completed Phase 3

~4540

0 / 18Eligibility criteria met