OncoMatch/Clinical Trials/NCT06606730
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Is NCT06606730 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Pembrolizumab for breast cancers.
Treatment: Pembrolizumab — OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study. The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months. This research will also take into account patients tolerance to treatment and quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 ≤10% expression (≤10%)
Estrogen receptor (ER) ≤10%
Required: PR (PGR) ≤10% expression (≤10%)
Progesterone receptor (PR) ≤10%
Required: HER2 (ERBB2) negative (negative)
HER2-negative as per ASCO/CAP guidelines
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — neoadjuvant
Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively)
Must have received: anti-PD-1 therapy (pembrolizumab) — neoadjuvant
Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles
Must have received: surgery — definitive
Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes)
Must have received: radiation therapy — adjuvant or planned
Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy
Cannot have received: anti-PD-1 therapy (pembrolizumab)
Exception: permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE
Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) ≥ 1,000 /µL; Platelets ≥ 100,000 /µL; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional upper limit of normal (ULN)
Liver function
Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN (Patients with Gilbert's disease with a total bilirubin ≤ 2.5 x ULN and direct bilirubin within normal limits are permitted); ASAT and ALAT ≤ 2.5 x ULN
Adequate organ and bone marrow functions. ... ANC ≥ 1,000 /µL; Platelets ≥ 100,000 /µL; Hemoglobin ≥ 9 g/dL; Creatinine clearance ≥ 30 mL/min ... Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN ... ASAT and ALAT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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