Clinical trial · no report yet · Phase 3
KEYNOTE-522
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
- NCT03036488 ↗
- Completed
- Merck Sharp & Dohme LLC
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 290 | |
| YouTube | 199 | |
| Podcasts | 156 | |
| X videos | 10 |
The trial
ClinicalTrials.gov- Official title
- 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)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Pembrolizumab; Carboplatin; Paclitaxel; Doxorubicin; Epirubicin; Cyclophosphamide; Placebo; Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim
- Arms
- Pembrolizumab + Chemotherapy · Experimental
- Placebo + Chemotherapy · Active comparator
- Enrollment
- 1,174
- Primary outcomes
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
- Event-free Survival (EFS) as assessed by Investigator
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Mar 7, 2017
- Primary completion
- Oct 14, 2025
- Results posted
- No
- Registry record
- NCT03036488 · updated Oct 29, 2025
Publications
linked from the registry- Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):1981-1991. doi: 10.1056/NEJMoa2409932. Epub 2024 Sep 15. PubMed 39282906
- Kuemmel S, Fasching PA, Schmid P, Harbeck N, Takahashi M, Untch M, Boileau JF, Cortes J, Dent R, O'Shaughnessy J, Pusztai L, Foukakis T, Park YH, Hui R, Cardoso F, Denkert C, Jia L, Pan W, Karantza V, McArthur H. Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 Study. Ann Surg Oncol. 2026 Jun;33(6):5550-5557. doi: 10.1245/s10434-026-19121-2. Epub 2026 Feb 25. PubMed 41739398
- Takahashi M, Mukai H, Takano T, Tsugawa K, Inoue K, Itoh M, Watanabe J, Tanabe Y, Yamamoto N, Miyoshi Y, Watanabe K, Mukohara T, Kong Y, Shimura M, Beca F, Schmid P, Iwata H. Pembrolizumab for Early-Stage Triple-Negative Breast Cancer: KEYNOTE-522 Japan Subgroup Analysis. Cancer Sci. 2026 Apr;117(4):1106-1116. doi: 10.1111/cas.70307. Epub 2026 Jan 14. PubMed 41536071
- Dent R, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Haiderali A, Jia L, Nguyen AM, Pan W, O'Shaughnessy J, Schmid P. Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study. J Natl Cancer Inst. 2024 Oct 1;116(10):1654-1663. doi: 10.1093/jnci/djae129. PubMed 38913881
- Favre-Bulle A, Huang M, Haiderali A, Bhadhuri A. Cost-Effectiveness of Neoadjuvant Pembrolizumab plus Chemotherapy Followed by Adjuvant Pembrolizumab in Patients with High-Risk, Early-Stage, Triple-Negative Breast Cancer in Switzerland. Pharmacoecon Open. 2024 Jan;8(1):91-101. doi: 10.1007/s41669-023-00445-8. Epub 2023 Nov 24. PubMed 37999854
- Takahashi M, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, Park YH, Im SA, Ahn JH, Mukai H, Huang CS, Chen SC, Kim MH, Jia L, Li XT, Tryfonidis K, Karantza V, Iwata H, Schmid P. Pembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342107. doi: 10.1001/jamanetworkopen.2023.42107. PubMed 37966841
- Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651. PubMed 35139274
- Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. PubMed 32450725
- Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549. PubMed 32101663