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NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

NCT06081244 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-11-19

No results posted yet for this study

Summary

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.

Conditions

Interventions

DRUG

Sacituzumab govitecan

10 mg/kg twice on Days 1 and 8 of a continuous 21-day treatment cycle

DRUG

Pembrolizumab

200 mg every 3 weeks (q3w)

Sponsors & Collaborators

Principal Investigators

  • Peter Schmid, Prof Dr PHD · Westdeutsche Studiengruppe GmbH

  • Nadia Harbeck, Prof Dr · Breast Centre, Dept. Obstetrics & Gynaecology and CCC Munich LMU University Hospital

  • Oleg Gluz, PD Dr · Breast Centre, Evang. Bethesda-Hospital, Moenchengladbach

  • Sherko Kuemmel, Prof Dr · Breast Centre, Kliniken Essen Mitte

  • Monika Graeser, PD Dr.. · Breast Centre, Evang. Bethesda-Hospital, Moenchengladbach

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT06081244 on ClinicalTrials.gov