EUCTR2017-004869-27-FR进行中（未招募）1 期
A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer (KEYNOTE-756) - Phase III study of pembrolizumab for high-risk early-stage ER+/HER2– breast cancer
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 1,140 人开始时间: 2018年10月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Type of Participant and Disease Characteristics
- •1. Participant has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size =2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2.
- •2. Has centrally confirmed ER+/HER2–, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
- •3. Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, and PD-L1 status.
- •Demographics
- •4. Is a male or female =18 years of age on the day of signing informed consent.
- •5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment
- •Male participants:
- •6. A male participant must agree to use a contraception as detailed in Appendix 3 of the protocol during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
- •Female participants:
- •7. A female participant is eligible to participate if she is not pregnant , not breastfeeding, and at least one of the following conditions applies:
- •a.) Not a woman of childbearing potential (WOCBP)
- •b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo.
- •Informed Consent
- •8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However the participant may participate in the main study without participating in future biomedical research.
- •Laboratory Evaluations
- •9. Has adequate organ function, as detailed in the protocol; all screening laboratory tests should be performed within 10 days prior to initiation of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 855
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 285
排除标准
- •Medical Conditions
- •1. Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
- •2. Has breast cancer with lobular histology.
- •3. Has bilateral invasive breast cancer.
- •4. Has metastatic (Stage IV) breast cancer.
- •5. Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
- •6. Has any of the following clinical lymph node staging per current AJCC staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
- •7. Has ER–, progesterone receptor positive breast cancer.
- •8. Participants who have undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or have undergone sentinel lymph node biopsy prior to study treatment.
- •9. Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.
- •10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- •11. Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- •12. Has a known history of active tuberculosis (Bacillus tuberculosis).
- •13. Has an active infection requiring systemic therapy.
- •14. Has a history or current evidence of any condition (eg, transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the trial, interfere with the participant’s involvement for the full duration of the trial, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator.
- •15. Has known psychiatric or substance abuse disorders that would may interfere with cooperation with the requirements of the trial.
- •16. Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
- •17. Has other significant cardiac disease, such as:
- •- History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months;
- •- Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
- •18. Has a known history of human immunodeficiency virus (HIV) infection.
- •19. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- •20. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Prior/Concomitant Therapy
- •21. Has received prior treatment for breast cancer.
- •22. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- •23. Has received a live vaccine within 30 days prior to the first dose
研究者
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