ArticleJournal of immunotherapy and precision oncology2026
Impact of Germline BRCA Status on Pathologic Complete Response (pCR) and Outcomes in Early TNBC Treated with Pembrolizumab-Based Neoadjuvant Chemotherapy (KEYNOTE-522 Regimen): A Real-World Study.
Article in Journal of immunotherapy and precision oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036488 (A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer), which is not on this map. Not yet cited in PubMed.
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A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
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Abstract
Introduction: Pembrolizumab-based neoadjuvant chemoimmunotherapy following the KEYNOTE-522 regimen (NCT03036488) is a standard treatment approach for stage II and III triple-negative breast cancer (TNBC). Real-world evidence on the impact of germline BRCA status on pathologic complete response (pCR) and survival outcomes remains limited. Methods: We performed a retrospective single-center cohort study of patients with stage II-III TNBC treated with a KEYNOTE-522 regimen between January 2021 and December 2023. Only patients with documented germline BRCA status were included. The primary end point was pCR rate, defined as achievement of ypT0/is ypN0. Secondary end points included treatment delivery (completion and early discontinuation), postneoadjuvant systemic therapy patterns, recurrence-free survival (RFS), and overall survival (OS). Categorical variables were compared using Fisher's exact test, and survival outcomes were estimated using Kaplan-Meier methods and compared with log-rank tests. Results: Among 1004 patients with breast cancer screened between 2021 and 2023, 125 had TNBC. After exclusion of patients who did not receive a KEYNOTE-522 regimen, had metastatic disease, underwent definitive surgery before neoadjuvant systemic therapy, had unretrievable BRCA status, or had other missing key eligibility data, 54 patients were eligible for analysis. The final cohort included 11 patients who were BRCA+ and 43 who were BRCA-. The BRCA+ patients were younger than BRCA- patients (median 38 vs 46 years; Conclusions: Germline
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