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OPT-PEMBRO: Adjuvant Pembrolizumab De-escalation in Early-stage TNBC with pCR
NCT06606730Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Jan 2033
- Countries
- 2
- Sponsor
- Unicancer
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 3, randomised, open-label trial of pembrolizumab in triple-negative breast cancer (TNBC) (2 arms), sponsored by Unicancer. Primary endpoint: Recurrence-free survival up to 8 years. Started Jul 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control
Administration of pembrolizumab for 6 months
Deescalation
Patients will be followed up according to standard practice for 4 years
03
Who it enrols
Adult patients with stage II-III triple-negative breast cancer who achieved a pathologic complete response after neoadjuvant chemotherapy and pembrolizumab, with adequate organ function and no history of severe autoimmune or cardiac disease.
04
Endpoints
Primary
Recurrence-free survival
Secondary
Acute and late toxicity
Patient reported outcome-CTCAE composite score
Quality of life questionnaire - Core 30
Quality of life questionnaire - Breast cancer module
5-level version of EQ-5D
Impact of Cancer Version 2 Question 11
Menstruation recovery rate
Impact on pregnancy
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