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Breast CancerOpen to EnrollmentPhase 3

BREAST: PERI-OPERATIVE: TNBC: SCARLET

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

Study snapshot

Title
SWOG S2212 SCARLET Breast Cancer perioperative TNBC
Malignancy
Breast, IBC
Stage
Stage 3
Disease setting
Adjuvant/Post-surgical
Line of therapy
Peri-operative
Investigational agent
Carboplatin, Paclitaxel, Pembrolizumab
Drug class
Chemotherapy, PD-1 inhibitor
Principal investigator
Greg Vidal, MD, PhD
Sponsor
SWOG
Path
ER negative, PR negative, HER2 negative, TNBC
Randomized
Yes
ClinicalTrials.gov ID
NCT05929768

Eligibility and objectives

Key eligibility criteria details

  • ER-, PR-, HER2- TNBC
  • Clinical stage either
    • T2-T4, N0, M0 or
    • T1-T3, N1-2, M0
    • No T4/N+, any N3, or inflammatory breast cancer
  • No prior systemic therapy for curative intent
  • No previous ipsilateral surgery for current breast surgery
  • ECOG PS 0-

Objective

  • Primary
    • Breast cancer event free survival
  • Secondary
    • Path CR
    • Residual cancer burden
    • Distant relapse-free survival
    • OS
    • Distant relapse-free interval
    • RFS
    • Safety
    • QOL

Treatment details