PREOPERATIVE WINDOW OF OPPORTUNITY STUDY WITH GIREDESTRANT (GDC-9545) OR TAMOXIFEN IN PREMENOPAUSAL WOMEN WITH ER[+]/HER2[-] & KI67=10% EARLY BREAST CANCER - MedOPP459 EMPRESS

Medica Scientia Innovation Research S.L.0 个研究点目标入组 92 人开始时间: 2023年2月2日最近更新: 2024年8月21日

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 92

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

入排标准

年龄范围: 18 至 65+（—）

入选标准

•Signed Informed Consent Form (ICF) prior to beginning specific protocol procedures., Participants who are able and willing to swallow, retain, and absorb oral medication., Age =18 years at time of signing ICF., Eastern Cooperative Oncology Group (ECOG) performance status of 0-1., Women with a well-determined premenopausal status as indicated in the protocol., Histologically confirmed invasive breast carcinoma, with all the following characteristics: a. Documented ER[+] tumor in accordance with American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al., 2020), assessed locally and defined as =1% of tumor cells stained positive. b. Documented HER2[-] tumor in accordance with 2018 ASCO/CAP guidelines (Wolff et al., 2018), assessed locally at baseline. Note: Diagnostic biopsy taken no more than 8 weeks prior to initiation of study treatment can be used as baseline. c. Ki67 score =10% analyzed locally and centrally confirmed (Nielsen et al., 2021). Note: Ki67 will be analyzed locally at the time of inclusion. Patients with basal Ki67=20% will be assessed locally and centrally confirmed retrospectively and patients with 10-19% will be assessed centrally before inclusion. d. Tumor size must be =1.0 cm in longest diameter by ultrasound as per Response Evaluation Criteria in solid Tumors (RECIST) criteria. Note: Patients with multifocal or multicentric breast cancer with at least one tumor lesion =1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathologic criteria for ER positivity and HER2 negativity., Willingness to provide a primary tumor tissue and blood sample obtained at baseline as well as a post-treatment tumor tissue and a blood sample (breast biopsy or breast surgery)., Patient has adequate bone marrow, liver, and renal function: • Hematological: absolute neutrophil count (ANC) = 1.5 x 109/L (1500/mL), platelet count = 100.0 x109/L, and hemoglobin = 9 g/dL (= 90g/L). Note: The blood counts are to meet the specified criteria without transfusion or growth factor support, unless it is clear that the bone marrow function is adequate and that any aberration has a clear and correctable cause, and the correction undertaken. • Hepatic: total serum bilirubin = 1.5’ institutional upper limit of normal (ULN) (patients with known Gilbert’s syndrome: = 3’ ULN); alkaline phosphatase (ALP) = 2.5 times ULN; aspartate transaminase (AST) and serum alanine transaminase (ALT) = 3’ times ULN. • Coagulation: The international normalized ratio (INR) < 1.5’ ULN and partial thromboplastin time (PTT or aPTT) < 1.5’ ULN (except for patients receiving anticoagulation therapy). For patients receiving warfarin, a stable INR between 2 and 3 is required. For patients receiving heparin, PTT (or aPTT) between 1.5 and 2.5’ ULN (or patient value before starting heparin treatment) is required. If anticoagulation therapy is required for a prosthetic heart valve, stable INR between 2.5 and 3.5 is permitted. • Renal: creatinine clearance = 60 mL/min for patients with creatinine levels above institutional normal., Negative serum pregnancy test result within 7 days prior to initiation of study treatment, and a negative urine pregnancy test within 24 hours prior to study treatment initiation. Note: Premenopausal women age =18 years with premenop

排除标准

•Progesterone receptor (PgR)[+] and ER[-] patients., Participants who have a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined in the protocol., Active cardiac disease or history of cardiac dysfunction including any of the following: • History or presence of symptomatic bradycardia or sick sinus syndrome. • Resting heart rate <50 bpm at screening. • History of angina pectoris, symptomatic pericarditis, myocardial infarction, or any cardiac arrhythmias (e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality) within 12 months prior to study entry. • History of documented congestive heart failure (New York Heart Association Class II-IV) or cardiomyopathy. • QT interval corrected through use of Fridericia’s formula (QTcF) >470 ms by at least three ECGs >30 minutes apart. • History of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes. • History or presence of an abnormal ECG that is clinically significant in the investigator’s opinion.• History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy cardiomyopathy, infiltrative cardiomyopathy, moderate-to-severe valve disease),, coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of long QT syndrome., Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study., Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization., Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection., Participants who have a known allergy or hypersensitivity to any of the study drugs or any of their excipients, Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 10 days after the final dose of giredestrant (GDC-9545), or within 9 months after the final dose of tamoxifen. Note: Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment and a negative urine pregnancy test within 24 hours prior to study treatment initiation., Patients with renal dysfunction who require dialysis., Participants who have had a serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening. Note: Participants who have fully recovered from serious or clinically significant infections at least 14 days prior to screening are eligible. If a participant exhibits signs or symptoms of potential COVID-19 infection and there is a reasonable suspicion of exposure, investigators are to follow the American Society of Clinical Oncology 2020 guidelines or institutional guidelines on testi

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发起方

Medica Scientia Innovation Research S.L.

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