Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Kesireddy, Meghana
Contact Information:
Anita Rogic
arogic@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05929768?term=NCT05929768&rank=1#participation-criteria
Summary
1.1 Primary Objective
a. To assess whether participants with early stage TNBC randomized to receive anthracycline-free, taxane-platinum
neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS)
compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with
pembrolizumab.
1.2 Secondary Objectives
a. To compare pathological complete response (pCR) and residual cancer burden (RCB) rates by randomized arm.
b. To compare pCR and RCB rates between randomized arms by tumor infiltrating lymphocytes (TIL) status.
c. To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL enriched subgroups.
d. To compare distant relapse-free survival and overall survival by randomized arm.
e. To compare invasive breast cancer-free survival after surgery between randomized arms in pCR and residual
disease groups.
f. To compare the safety and tolerability by randomized arm among those that initiate therapy.
1.3 Translational Medicine Objective
a. To evaluate concordance and accuracy of an Automated stromal TIL (sTIL) algorithm vs. Central pathologist
assessed sTILs quantification.
1.4 PRO Objectives
a. Quality of Life:
1. Primary: To compare patient-reported fatigue at 3 weeks after the last neoadjuvant systemic therapy (NAST) dose
and, separately, at 18 months after randomization, using the PROMIS Fatigue-7a in participants undergoing NAST
with taxane-platinum-anthracycline chemoimmunotherapy vs taxane-platinum chemo-immunotherapy.
2. Secondary: To compare physical function experienced by participants undergoing neoadjuvant systemic
chemotherapy (NAST) with taxaneplatinum-anthracycline chemo-immunotherapy vs taxane-platinum
chemo-immunotherapy, within 3-5 weeks post last neoadjuvant systemic therapy dose using the PROMIS-29 Profile
physical function subscale score.
3. Secondary: To compare physical function experienced by participants undergoing NAST
taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy at 18 months post
registration
using the PROMIS-29 Profile physical function subscale score.
4. Exploratory: To compare other PROMIS-29 Profile subscale scores (sleep disturbance, depression, anxiety, social,
pain interference, and pain sensitivity) and GP5 question response by arm within 3-5 weeks post last neoadjuvant
systemic therapy dose and at 18 months post registration.
5. Exploratory: To compare the GP-5 item scores by arm within 3-5 weeks post last neoadjuvant systemic therapy
dose and at 18 months post registration.
b. Patient-Reported Symptoms of Treatment: To compare select patient-reported outcomes using the Common
Terminology Criteria for Adverse Events (PROCTCAE) by arm.
1.5 Banking Objectives
a. To bank physical specimens and digital slides for future correlative studies