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Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer

NCT06175390 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-02-06

No results posted yet for this study

Summary

This is a phase II study, preceded by a safety run-in, with two independent cohorts (cohort A in early Triple Negative Breast Cancer (TNBC) patients and cohort B in late in metastatic TNBC patients) designed to evaluate the efficacy of atezolizumab, tiragolumab and chemotherapy.

Conditions

Interventions

RADIATION

68Ga-FAPI-46 PET/CT

Cohort A: Tumor assessments by 18F-FDG PET/CT (per PERCIST v1.0) will be performed at: baseline, after the first 2 treatment cycles (between C2D15 and C3D1), and before surgery (after the last administration of neoadjuvant chemotherapy) Tumor assessment by 68Ga-FAPI-46 PET/CT will be performed at: baseline and before surgery (after the last administration of neoadjuvant chemotherapy). Cohort B: Tumor assessments by 18F-FDG PET/CT per PERCIST v1.0 will be performed at baseline, every 8 weeks (+/- 1 week) for the first 24 weeks, and every 12 weeks (+/- 1 week) thereafter until disease progression or treatment discontinuation, whichever is later. Tumor assessments by 68Ga-FAPI-46 PET/CT will be performed at baseline and after the first 2 treatment cycles and will be synchronized with 18F-FDG PET/CT.

BIOLOGICAL

Tumor samples analysis

Patients will undergo a mandatory biopsy of the primary tumor at baseline, after the first 2 treatment cycles and during the surgery. A lymph node biopsy will be performed at baseline if feasible in cohort A, and and in case of disease progression for cohort B (if clinically feasible). In addition to the usual morphological and immunohistochemical (ER, PR, HER2+, CPS score, PD-L1 status with SP142 …) analyses in the cohort A and cohort B , exploratory analyses will be performed.

BIOLOGICAL

Blood samples analysis: Circulating Tumor DNA

Blood samples will be collected at baseline. In addition for cohort A at cycles 2 and 3, within 21 days before surgery, 10 to 21 days after surgery and at cycle 8 after surgery. In addition for cohort B after the first 2 treatment cycles and in case of disease progression (if clinically feasible).

Sponsors & Collaborators

Principal Investigators

  • François-Clément Bidard, PhD · Institut Curie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2026-08-15
Completion
2029-02-15

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175390 on ClinicalTrials.gov