Randomized open-label multicenter phase II trial comparing first-line Olaparib versus CDK4/6i plus endocrine therapy in patients with gBRCAmut-associated HR(+)/HER2(-) recurrent unresectable and/or metastatic breast cancer (OPERA trial)

Korea University Anam Hospital0 个研究点目标入组 66 人开始时间: 待定最近更新: 2021年12月2日

试验速览

阶段: 未知
状态: 招募中
发起方: Korea University Anam Hospital
入组人数: 66

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19?(Year) 至 o Limit（—）
性别: Female

入选标准

•1)Female patients aged =19 years at the time of informed consent.
•2)Premenopausal or postmenopausal and evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
•Postmenopausal is defined as:
•?Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
•?Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
•?radiation-induced oophorectomy with last menses >1 year ago
•?chemotherapy-induced menopause with >1 year interval since last menses
•?surgical sterilisation (bilateral oophorectomy)
•3)Histologically or cytologically proven diagnosis of HR+, HER2- breast cancer with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy
•?Documented HR-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines24, assessed locally and defined as = 1% of tumor cells stained positive based on the most recent tumor biopsy (or archived tumor sample)
•?Documented HER2-negative tumor assessed locally and defined as meeting one ofthe following sets of criteria:
•– HER2 immunohistochemistry (IHC) score of 0 or 1+
•– HER2 IHC score of 2+ accompanied by a negative fluorescence, chromogenic,or silver in situ hybridization test indicating the absence of HER2 gene amplification
•– HER2/CEP17 ratio of <2.0 based on the most recent tumor biopsy (or archived tumor sample)
•4)Patient with known pathogenic germline BRCA1/2 mutation
•5)Must not have a history of prior treatment with CDK4/6 inhibitors or PARP inhibitors in recurrent/metastatic setting. However, if a CDK4/6 inhibitor was administered for early stage cancer, patients who have survived with disease-free status > 1 year after the end of treatment can be enrolled.
•6)Must have more than one prior cytotoxic chemotherapy to treat breast cancer for adjuvant or neoadjuvant purpose
•7)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
•8)Patient must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1); patients with only bone metastases can be enrolled once lytic lesions are identified.
•9)Adequate bone marrow and organ function measured within 28 days prior to administration of study treatment as defined below:
•Haemoglobin = 10.0 g/dL with no blood transfusion in the past 28 days
•Absolute neutrophil count (ANC) = 1.5 x 109/L
•Patients must have creatinine clearance estimated of =51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test :
•Estimated creatinine clearance =(140-age [years]) x weight (kg) (x F)a
•serum creatinine (mg/dL) x 72
•a where F=0.85 for females and F=1 for males.
•10)Patients must have a life expectancy = 16 weeks
•11) Written informed consent

排除标准

•Patients with any of the following characteristics/conditions will not be included in the study:
•1)Patient has received previous treatment with a CDK4/6 inhibitor or PARP inhibitor for recurrent/metastatic disease. However, if a CDK4/6 inhibitor was administered for early-stage cancer, patients who have survived with disease-free status for >1 year after the end of treatment can be enrolled.
•2)Patient with known hypersensitivity to CDK4/6 inhibitor or olaparib or any of the excipients of the product.
•3)Initially metastatic breast cancer (de novo stage 4) or recurrent breast cancer who had never received cytotoxic chemotherapy for adjuvant or neoadjuvant purpose
•4)Patient with only benign or unknown significant germline BRCA mutation
•5)HER2 positive or triple negative breast cancer (TNBC)
•?Documented HER2-postive tumor assessed locally and defined as meeting one ofthe following sets of criteria:
•– HER2 IHC score of 2+ accompanied by a positive fluorescence, chromogenic,or silver in situ hybridization test indicating the presence of HER2 gene amplification
•– HER2/CEP17 ratio of =2.0 based on the most recent tumor biopsy (or archivedtumor sample)
•?Triple negative breast cancer (TNBC) is defined as HER2- and HR- according to the ASCO/CAP guidelines24.
•6)Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
•7)Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV). Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). Baseline viral assessment is not required in patients with no known infection.
•8)Major surgery within 4 weeks of the first dose of the investigational product or not fully recovered from any side effects of previous procedures.
•9)Other malignancy unless curatively treated with no evidence of disease for =5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
•10) Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
•11) Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
•12) Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome..
•13)Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
•14)Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythm

研究者

发起方

Korea University Anam Hospital

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