← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.
Select...
I haven't received any systemic therapy for my advanced TNBC.
Select...
I am fully active or can carry out light work.
Select...
My blood and organs are functioning well.
Select...
My cancer is classified as HER2-low.
Select...
My heart is healthy and functions well.
Select...
I have been screened for hepatitis B with specific test results.
Select...
I do not have HIV, or if I do, it is under control with treatment.
Select...
My cancer has spread and can be measured outside of the bone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and two consecutive occasions at least 4 weeks apart (up to approximately 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Duration of Response (DOR)
Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig
OS rate at 12 months
+4 more

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
~4340

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,991 Total Patients Enrolled
159 Trials studying Breast Cancer
91,307 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,419 Total Patients Enrolled
137 Trials studying Breast Cancer
71,936 Patients Enrolled for Breast Cancer

Media Library

Nab-Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT05852691 — Phase 2
Breast Cancer Research Study Groups: Arm A, Arm B
Breast Cancer Clinical Trial 2023: Nab-Paclitaxel Highlights & Side Effects. Trial Name: NCT05852691 — Phase 2
Nab-Paclitaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852691 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Arm A been granted authorization by the Food and Drug Administration?

"With only limited clinical data supporting the safety of Arm A, our team has assigned it a score of 2. This is due to its Phase 2 status which implies that efficacy testing has yet to be conducted."

Answered by AI

How many people can take part in this medical research?

"Yes, the information on clinicaltrials.gov confirms that this medical study is actively searching for participants. This trial was first advertised on June 29th 2023 and has recently been updated to reflect changes made by researchers. The total number of patients sought out is 160 from 1 location."

Answered by AI

Are participants currently being enrolled in this clinical experiment?

"Affirmative, according to the information on clinicaltrials.gov this trial is currently enrolling patients. It was initially posted June 29th 2023 and most recently updated on June 1st 2023, with a goal of recruiting 160 individuals from one medical center."

Answered by AI
~107 spots leftby Dec 2025