EUCTR2020-001984-10-PL进行中（未招募）1 期
A PHASE II, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMPARED WITH PHYSICIAN'S CHOICE OF ENDOCRINE MONOTHERAPY IN PATIENTS WITH PREVIOUSLY TREATED ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Age >= 18 years of age
- •For women: postmenopausal or premenopausal/perimenopausal status
- •oAge >= 60 years
- •oAge < 60 years and >= 12 months of amenorrhea plus follicle-stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin releasing hormone agonist or antagonist
- •oDocumented bilateral oophorectomy
- •oPremenopausal/perimenopausal or men, be willing to undergo and maintain treatment with approved LHRH-agonist therapy
- •Histologically or cytologically confirmed diagnosis of locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- •Disease progression after treatment with one or two lines of systemic therapy in the locally advanced or metastatic setting
- •Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists guidelines
- •Documented HER2-negative tumor assessed locally
- •Availability of the most recently collected and representative tumor tissue specimen, with associated de identified pathology report, and whenever possible, from a metastatic site of disease
- •Measurable disease as defined per Response Evaluation Criteria in Solid Tumors, Version 1
- •Eastern Cooperative Oncology Group Performance Status 0-1
- •Life expectancy of > 6 months
- •Adequate organ function
- •INR < 1.5 × upper limit of normal (ULN) and PTT (or aPTT) < 1.5 × ULN
- •Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade <= 1
- •For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods with a failure rate of < 1% per year during the treatment period, for 8 days after the final dose of GDC-9545
- •For men: agreement to remain abstinent or use a condom, and must refrain from donating sperm for 8 days after the final dose of GDC-9545 to avoid exposing the embryo
- •For the assigned to the control arm, women or men must comply with local prescribing guidelines regarding contraception for the chosen endocrine monotherapy Willing and able to use an electronic device for PRO data collection
- •For patients enrolled in an extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Prior treatment with a SERD, with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
- •Treatment with any investigational therapy within 28 days prior to randomization
- •Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
- •History of malignancy other than breast cancer within 5 years prior to screening
- •Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- •Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- •Active cardiac disease or history of cardiac dysfunction
- •Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis
- •Known HIV infection
- •Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery, including gastric resection, potentially affecting enteral absorption
- •Serious infection requiring oral or IV antibiotics within 14 days prior to randomization
- •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
- •Known allergy or hypersensitivity to any of the study drugs or any of their excipients
- •For premenopausal/perimenopausal patients or male patients: known hypersensitivity to LHRH agonists
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 days after the final dose of GDC-9545, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of endocrine monotherapy
研究者
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