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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06606730 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 ≤10% expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR ≤10% expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify