jRCT1070250028招募中不适用
Retrospective Real-world Observational Study on Abemaciclib Plus Endocrine Therapy Versus Endocrine Monotherapy as First-Line Treatment in Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (JBCRG-S04)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 主要终点
- Time to Next Treatment (TTNT)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 No limit（—）
入选标准
- •Eligible subjects enrolled in JBCRG-C10 (C10 Cohort) or ABCD Project (ABCD Cohort)
- •Eligibility Criteria
- •C10 Cohort:
- •Subjects enrolled in JBCRG-C10 and meeting the following criteria:
- •ABE was initiated as first-line treatment* for AMBC in combination with an aromatase inhibitor (AI) or fulvestrant (FUL) as ET.
- •Definition of first-line treatment: The first treatment after being diagnosed with AMBC.
- •No intention of refusal for secondary use of data.
- •ABCD Cohort:
- •Subjects enrolled in the ABCD project and meeting the following criteria:
- •Menopausal status is not considered.
- •Confirmed to be estrogen receptor (ER) positive (1% or more) or progesterone receptor (PgR) positive (1% or more).
- •Confirmed to be HER2 negative (Definition of HER2 negative: IHC 1+ or less, or FISH/DISH negative).
- •ABE was initiated as first-line treatment* for AMBC in combination with AI or FUL as ET (ABE+ET combination group). Alternatively, AI or FUL as ET was initiated as first-line treatment (ET alone group).
- •Definition of first-line treatment: The first treatment after being diagnosed with AMBC.
- •In the case of the ET monotherapy group, ET was administered as first-line treatment for more than 2 months (in case of the comparative analysis with the C10 cohort).
- •If ABE was used as perioperative treatment, the period from the last administration date to the AMBC diagnosis date is 6 months or more.
- •Treatment was initiated on or after January 1,
- •No indication of refusal for secondary use of data.
排除标准
- 未提供
结局指标
主要结局
Time to Next Treatment (TTNT)
the Time to Next Treatment (TTNT) from the start of first-line treatment to the start of second-line treatment in the ABE+ET combination group of the C10 Cohort
次要结局
- Chemotherapy Free Survival (CFS)(in the ABE+ET combination group of the C10 Cohort and the ABCD Cohort)
研究者
相似试验
招募中
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3938577 in Healthy Participants and Participants with Type 1 Diabetes Mellitus.Type 1 Diabetes MellitusCTIS2023-510365-10-00Eli Lilly & Co.70
进行中（未招募）
1 期
A trial in healthy volunteers to study safety, tolerability, CS014-levels and effects in the body, after single and repeated doses of CS014, for the first time in humans.Cardiovascular diseaseCTIS2024-510878-24-00Cereno Scientific AB48
招募中
1 期
A Phase 1 Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy orNivolumab in Advanced Solid TumorsCTIS2022-500930-27-00Celgene Corp.149
已完成
不适用
Japanese multicenter REsearch of COVID-19 by assEmbling Real-world dataCOVID-19JPRN-UMIN000047056ippon Medical School Musashikosugi Hospital4,700
招募中
1 期
A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants.HealthyMedDRA version: 21.1Level: PTClassification code: 10053643Term: Neurodegenerative disorder Class: 100000004852CTIS2023-504838-21-00Eli Lilly & Co.69