JPRN-jRCT2061230009招募中2 期
eoadjuvant and Adjuvant Olaparib plus Pembrolizumab following Platinum based chemotherapy plus Pembrolizumab for germline BRCA mutated Triple Negative Breast Cancer (WJOG14020B) - OPERETTA
Takahashi Yuko0 个研究点目标入组 23 人开始时间: 2023年4月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- > 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Male/female subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive breast cancer
- •2)Have histologically confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
- •3)Confirmed germline BRCA 1/2 mutated.
- •4)Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per AJCC for breast cancer staging criteria version 7 as assessed by the investigator based on radiological and/or clinical assessment:
- •T1c, N1-N2
- •T4a-d, N0-N2
- •5)It has been confirmed that there is no distant metastasis to each organ by the following tests. Chest: Contrast CT or FDG-PET/CT Abdominal: Contract CT* or FDG-PET/CT Bone: Bone scintigraphy or FDG-PET/CT Brain: In the case of no central nervous system symptoms, examination for brain metastasis is not required.
- •6)The subject (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •7)Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •8)Have adequate organ function as defined in the protocol. Specimens must be collected within 14 days prior to the start of study treatment.
排除标准
- •1) Subjects who has a positive urine pregnancy test within 72 hours prior to registration
- •2) Has diagnosed as inflammatory breast cancer.
- •3) 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 .
- •4) Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.
- •5) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •6) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •7) Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •8) Has severe hypersensitivity (more than Grade 3) to pembrolizumab and investigational drugs used in this study and/or any of their excipients.
- •9) Has active autoimmune disease that has required systemic treatment in the past 2 years
- •10) Has a history of (non-infectious) pneumonitis/interstitial lung disease .
- •11) Has an active infection requiring systemic therapy.
- •12) Has a known history of Human Immunodeficiency Virus (HIV) infection.
- •13) Has a known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
- •14) Has a known history of active TB (Bacillus Tuberculosis).
- •15) Has a history or current evidence of any condition, therapy, or laboratory abnormality.
- •16) Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •17) Is pregnant or breastfeeding, or expecting to conceive or father children.
- •18) Has had an allogenic tissue/solid organ transplant.
- •19) Has received pre-treatment with Olaparib or other PARP inhibitors.
- •20) Has significant cardiovascular disease
- •21) Has a resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions.
- •22) Subject has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- •23) Subject received colony-stimulating factors within 28 days prior to the first dose of study intervention.
- •24) Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •25) Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption.
- •26) Is, in the judgement of the investigator, unlikely to comply with the study procedures, restrictions, and requirements of the study.
- •27) Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.
- •28) Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.
研究者
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