Study Summary
This trial is testing a new cancer treatment of pembrolizumab (MK-3475) combined with chemotherapy vs. chemotherapy alone in participants who have triple negative breast cancer.
- Triple Negative Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Up to approximately 8 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Placebo + Chemotherapy
1 of 2
Pembrolizumab + Chemotherapy
1 of 2
Active Control
Experimental Treatment
1174 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Virginia | 50.0% |
| Michigan | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- Pérez-García, José, Jesús Soberino, Fabricio Racca, María Gion, Agostina Stradella, and Javier Cortés. 2020. “Atezolizumab in the Treatment of Metastatic Triple-negative Breast Cancer”. Expert Opinion on Biological Therapy. Informa UK Limited. doi:10.1080/14712598.2020.1769063.
- Schmid, Peter, Javier Cortes, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, Carsten Denkert, et al.. 2020. “Pembrolizumab for Early Triple-negative Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1910549.
- Schmid, Peter, Javier Cortes, Rebecca Dent, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, et al.. 2022. “Event-free Survival with Pembrolizumab in Early Triple-negative Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2112651.
- 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.
- 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.
- 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.
- 2017. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03036488.
Frequently Asked Questions
What are the research objectives of this clinical trial?
"The primary outcome of this clinical trial is Event-free Survival (EFS) as assessed by Investigator, which will be evaluated over a Up to approximately 27-30 weeks time frame. Secondary outcomes include 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, defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed" - Anonymous Online Contributor
Is it possible to sign up for this experiment right now?
"This research is not currently enrolling new patients. The study was originally posted on March 7th, 2017 and last updated on July 8th, 2022. However, there are 2436 other trials related to triple negative breast neoplasms that are actively recruiting and 2979 for Pembrolizumab if you're interested in participating in active clinical trials." - Anonymous Online Contributor
Is this a new clinical trial?
"Since 1997, when the first study occurred in sponsored by Alfacell, Pembrolizumab has been researched. The drug went through Phase 3 approval after the initial 300-person trial in 1997. As of now, there are 2979 active studies involving Pembrolizumab across 4472 cities and 88 countries." - Anonymous Online Contributor
How many locations are conducting this research?
"Presently, patients are being accepted at Christiana Hospital (Site 0029) in Newark, Delaware; Nyack Hospital Infusion Center (Site 0059) in Nyack, New York; Oncology Hematology Care, Inc. (Site 8011) in Cincinnati, Ohio; and 54 other locations." - Anonymous Online Contributor
What is the standard Pembrolizumab dosage for patients?
"Pembrolizumab, while most commonly used to treat melanoma, can also help patients suffering from neoplasm metastasis, malignant melanoma of skin, and corticotropin." - Anonymous Online Contributor
How many people are in this experiment?
"This particular study is no longer looking for patients to enroll. However, there are 2436 trials currently recruiting patients with triple negative breast neoplasms and 2979 trials actively recruiting patients that hope to receive Pembrolizumab." - Anonymous Online Contributor
Has Pembrolizumab been cleared for therapeutic use in the United States?
"The safety of Pembrolizumab is thought to be high as it is a Phase 3 trial, meaning there is both evidence of efficacy and multiple rounds data supporting safety." - Anonymous Online Contributor
What other types of research has been conducted using Pembrolizumab?
"Pembrolizumab was first studied in 1997 at Spectrum Health Hospital - Butterworth Campus. 21532 trials have been completed to date, with 2979 active clinical trials presently underway - many of which are based in Newark, Delaware." - Anonymous Online Contributor