2022-500764-35-00招募中4 期
CAPTOR-BC: COMPREHENSIVE ANALYSIS OF SPATIAL, TEMPORAL AND MOLECULAR PATTERNS OF RIBOCICLIB EFFICACY AND RESISTANCE IN ADVANCED BREAST CANCER PATIENTS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 125
- 主要终点
- progression-free survival
研究概览
简要总结
The co-primary objective of this trial are estimates for the survival rates of progression free survival (PFS) at months 12 and overall survival (OS) at months 12.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with CDK4/6 inhibitors is allowed in the adjuvant setting)
- •Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
- •Written informed consent prior to beginning of trial specific procedures
- •Subject must be female and aged ≥ 18 years on the day of signing informed consent
- •Locally advanced or metastatic breast cancer not amenable to curative treatment
- •Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory
- •Histologically confirmed ER positive and/ or PgR positive breast cancer determined by core biopsy according to local in-house standard
- •QTcF interval < 450 ms
- •Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
- •Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment
排除标准
- •Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
- •Patients who are not treated for advanced HRpos/HER2neg breast cancer in the first line therapy setting
- •Patients not eligible for treatment with ribociclib according to SmPC or investigator’s discretion
- •Patients who are pregnant or lactating
- •Patients with existing or patients who are at significant risk of developing QTc prolongation. This includes patients with long QT syndrome, uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia, electrolyte abnormalities
- •Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib
- •Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive)
- •Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea)
- •Patients who do not agree to collection of biospecimens samples (blood, stool, tissue)
结局指标
主要结局
progression-free survival
progression-free survival
overall survival
overall survival
次要结局
- progression-free survival
- overall survival
- health related quality of life FACT-G/FACT-B
- occurence of side effects
研究者
Clinical Trial Team
Scientific
Institut Für Frauengesundheit GmbH
研究点 (125)
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