JBCRG-M10（INDUCE）｜Clinical Trials｜Japan Breast Cancer Research Group

JBCRG-M10（INDUCE） NEW: Randomized phase II trial evaluating the efficacy of paclitaxel+bevacizumab INDUCtion followed by atEzolizumab+nab-paclitaxel for PD-L1-positive metastatic triple negative breast cancer

Objectives: 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.

Subjects: PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer

Endpoints: Primary endpoint
Progression-free survival (PFS) *
Whether the PFS is prolonged with statistical significance (level of significance, one-sided 10%) in the induction therapy group compared to the standard treatment group will be evaluated.
* In this research, all antitumor effects will be assessed based on the evaluation by the primary physician.

Key secondary endpoints
(1)2-year PFS rate
(2)2-year PFS rate in patients with non-PD on the first imaging assessment in the induction therapy group

The standard treatment group and the induction therapy group will be compared and evaluated.

Trial Period: From Date of publication in jRCT (04. Jun. 2024) to 30. Sep. 2028

Lead Principal Investigator: Yukinori Ozaki
Department of Breast Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Regimen: 1. Induction therapy group
Induction therapy will be administered in Cycles 1 and 2. PTX 90 mg/m2 will be intravenously infused on Day 1, Day 8, and Day 15, and bevacizumab 10 mg/kg will be intravenously infused on Day 1 and Day 15 in 28-day cycles. From Cycle 3, atezolizumab 840 mg will be intravenously infused on Day 1 and Day 15, and nab-PTX 100 mg/m2 will be intravenously infused on Day 1, Day 8, and Day 15 in 28-day cycles. A series of treatments will consist of 2 cycles of induction therapy + Immunochemotherapy.
* In the induction therapy group, efficacy and safety will be evaluated in a series of treatments including 2 cycles of induction therapy.

2. Standard treatment group
Atezolizumab 840 mg will be intravenously infused on Day 1 and Day 15, and nab-PTX 100 mg/m2 will be intravenously infused on Day 1, Day 8, and Day 15 in 28-day cycles.

Clinical Trials