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Anti-microtubule agent
Immunotherapy for Triple-Negative Breast Cancer
Phase 2
Recruiting
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
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 belowSelect...
My breast cancer is advanced, cannot be surgically removed, and lacks HER2, ER, and PgR.
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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.
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My cancer is classified as HER2-low.
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I have been screened for hepatitis B with specific test results.
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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:Select...
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
Treatment Details
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
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,092,962 Total Patients Enrolled
158 Trials studying Breast Cancer
90,490 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,256 Total Patients Enrolled
136 Trials studying Breast Cancer
71,144 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that would make it unsafe for me to take a new drug.You have tested negative for hepatitis B surface antigen (HBsAg) at the screening.I have not received a live vaccine in the last 28 days.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have active tuberculosis.I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.I haven't had any cancer except for the one being studied or low-risk cancers in the last 5 years.I have previously been treated with specific immune therapy drugs.I have had cancer spread to the lining of my brain and spinal cord.I have high calcium levels in my blood.My breast cancer is advanced, cannot be surgically removed, and lacks HER2, ER, and PgR.I have had a previous transplant of stem cells or an organ.I have a history or risk of irregular heartbeats due to heart conditions or electrolyte issues.I have not taken any antibiotics or antiviral drugs in the last week.You have a history of a heart test (ECG) showing a significant abnormality.I have not had major surgery in the last 4 weeks.My tumor has been tested and shows PD-L1 expression.I haven't received any systemic therapy for my advanced TNBC.I am fully active or can carry out light work.My blood and organs are functioning well.My cancer is classified as HER2-low.I have or had an autoimmune disease or immune deficiency.I haven't taken any steroids or immune-suppressing drugs in the last 2 weeks.I have not had a heart or stroke issue in the last 3 months.I am allergic to ingredients in nab-paclitaxel.I have brain metastases that are untreated or getting worse.You have difficulty getting medicine through your veins.I have had lung conditions like pulmonary fibrosis but not due to radiation.My heart is healthy and functions well.You don't have hepatitis C virus, or if you tested positive for it before, you don't have it anymore.I need frequent procedures to remove fluid from my chest, heart area, or abdomen.You have a measurable tumor according to specific medical guidelines.I have been screened for hepatitis B with specific test results.You have had serious allergic reactions to certain types of medications made from human or animal proteins.I do not have HIV, or if I do, it is under control with treatment.My cancer has spread and can be measured outside of the bone.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
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