2023-509671-17-00招募中3 期
I3Y-MC-JPCF: monarchE: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,790
- 试验地点
- 188
- 主要终点
- Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
- •The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •The participant has adequate organ function.
- •The participant is able to swallow oral medications.
- •The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
- •The participant must have undergone definitive surgery of the primary breast tumor.
- •The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
- •Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: 4 or more positive axillary lymph nodes, Tumor size of at least 5 centimeters, Grade 3 defined as at least 8 points on the Bloom Richardson grading system, Ki-67 index by central analysis of ≥20% on untreated breast tissue.
- •The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
- •The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
- •Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
- •Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
排除标准
- •Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
- •The participant has active systemic infections or viral load.
- •The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
- •Participants with inflammatory breast cancer.
- •Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
- •Females who are pregnant or lactating.
- •The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
- •The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
- •The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene.
- •The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- •The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE).
研究组 & 干预措施
TAMOXIFEN , LETROZOLE , ANASTROZOLE , EXEMESTANE
Auxiliary
干预措施: TAMOXIFEN (Drug)
TAMOXIFEN , LETROZOLE , ANASTROZOLE , EXEMESTANE
Auxiliary
干预措施: LETROZOLE (Drug)
TAMOXIFEN , LETROZOLE , ANASTROZOLE , EXEMESTANE
Auxiliary
干预措施: EXEMESTANE (Drug)
TAMOXIFEN , LETROZOLE , ANASTROZOLE , EXEMESTANE
Auxiliary
干预措施: ANASTROZOLE (Drug)
结局指标
主要结局
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (188)
Loading locations...
相似试验
招募中
2 期
A Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing's Sarcoma2023-506772-28-00Eli Lilly & Co.30
招募中
3 期
A randomized, controlled, open-label, phase III-trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) intermediate to high risk, HR+/HER2- early breast cancer (ADAPTlate)2023-509242-35-00WSG Westdeutsche Studiengruppe GmbH1,700
招募中
2 期
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast CancerMetastatic Breast Cancer2023-507175-22-00Eli Lilly & Co.1
招募中
3 期
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)2023-504031-41-00AstraZeneca AB2,049
招募中
3 期
Study comparing two standard treatments as initial metastatic treatment among patients with visceral metastasis of ER+ HER2- breast cancer, high burden disease: chemotherapy and combination of hormonotherapy with abemaciclib.2024-513005-31-00Unicancer180