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Clinical Trials List

Protocol NumberMK3475-522
NCT Number(ClinicalTrials.gov Identfier)NCT03036488
Completed

2017-03-01 - 2019-12-31

Phase III

Terminated6

ICD-10C50

Malignant neoplasm of breast

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

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)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/14

Investigators and Locations

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Kuo-Ting Lee Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

  • 褚乃銘 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chun-Yu Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Completed

Audit

None

Principal Investigator Shin-Cheh Chen
Linkou Chang Gung Medical Foundation

Taiwan National PI

陳訓徹

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Completed

Audit

CRO

Condition/Disease

Triple Negative Breast Neoplasms

Objectives

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

Test Drug

學名：Pembrolizumab (MK-3475) ；商品名：KEYTRUDA®/吉舒達®

Active Ingredient

Pembrolizumab (Humanized anti-PD-1 mAb)

Dosage Form

Injection

Dosage

100 mg/ 4 mL/

Endpoints

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

Inclution Criteria

Inclusion Criteria:

Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:

T1c, N1-N2
T2, N0-N2
T3, N0-N2
T4a-d, N0-N2
Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
Demonstrates adequate organ function.
Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.

Exclusion Criteria

Exclusion Criteria:

Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
Has received a live vaccine within 30 days of the first dose of study treatment.
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Has a known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or Hepatitis C.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has an active infection requiring systemic therapy.
Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
Has a known hypersensitivity to the components of the study treatment or its analogs.
Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    855 participants

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