Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

August 15, 2026

Study Completion Date

February 15, 2029

Conditions
Triple Negative Breast Cancer
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).

Trial Locations (2)

92210

RECRUITING

Institut Curie, Paris

RECRUITING

Institut Curie, Saint-Cloud

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Institut Curie

OTHER