RecruitingPhase 2NCT06793553

Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC

Randomized Phase II Trial Evaluating the Efficacy of Paclitaxel+Bevacizumab INDUCtion Followed by at atEzolizumab+Nab-paclitaxel for PD-L1-positive Metastatic Triple Negative Breast Cancer (JBCRG-M10, CMA-0196) (INDUCE Trial)


Sponsor

Japan Breast Cancer Research Group

Enrollment

106 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this research is to evaluate the efficacy of the treatment strategy to administer atezolizumab + nab-paclitaxel (PTX) following 2 cycles of induction therapy with PTX + bevacizumab (induction treatment strategy) in programmed cell death ligand-1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) in comparison with the standard atezolizumab + nab-PTX therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a two-step treatment approach for advanced triple-negative breast cancer (a subtype that is harder to treat) that has a specific marker called PD-L1. Patients first receive a combination of chemotherapy drugs, then switch to an immunotherapy-based regimen. **You may be eligible if...** - You are 18 or older with metastatic or unresectable triple-negative breast cancer - Your tumor tests positive for PD-L1 (a marker that helps predict response to immunotherapy) - You have not received prior treatment for advanced disease (or relapsed at least 6 months after completing earlier treatment) - Your overall health status is adequate (ECOG 0–1) **You may NOT be eligible if...** - Your tumor is PD-L1 negative - You have already received immunotherapy for advanced disease - You have active brain metastases - You have significant heart or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInduction therapy

2 cycles of PTX+ bevacizumab induction therapy followed by atezolizumab+nab-PTX


Locations(1)

Yukinori Ozaki

Koto-ku, 3-8-31, Tokyo, Japan

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NCT06793553


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