neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 31
- 主要终点
- Percent Change From Baseline to 2 Weeks in Ki67 Expression
研究概览
简要总结
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have postmenopausal status.
- •Adenocarcinoma of the breast.
- •Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
- •Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
- •Primary breast cancer that is suitable for baseline core biopsy.
- •Have adequate organ function.
排除标准
- •Bilateral invasive breast cancer.
- •Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
- •Inflammatory breast cancer.
- •Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
- •Prior radiotherapy to the ipsilateral chest wall for any malignancy.
- •Prior anti-estrogen therapy.
研究组 & 干预措施
Abemaciclib + Anastrozole
Abemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Abemaciclib (Drug)
Abemaciclib + Anastrozole
Abemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Loperamide (Drug)
Abemaciclib + Anastrozole
Abemaciclib (150 milligrams [mg]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Anastrozole (Drug)
Abemaciclib
Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Abemaciclib (Drug)
Abemaciclib
Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Loperamide (Drug)
Abemaciclib
Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
干预措施: Anastrozole (Drug)
Anastrozole
Anastrozole (1 mg) is given orally QD for 2 weeks.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.
干预措施: Abemaciclib (Drug)
Anastrozole
Anastrozole (1 mg) is given orally QD for 2 weeks.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.
干预措施: Loperamide (Drug)
Anastrozole
Anastrozole (1 mg) is given orally QD for 2 weeks.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.
干预措施: Anastrozole (Drug)
结局指标
主要结局
Percent Change From Baseline to 2 Weeks in Ki67 Expression
时间窗: Baseline, 2 Weeks
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.
次要结局
- Percentage of Participants With Pathologic Complete Response (pCR)(From Start of Treatment Up to 16 Weeks)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response(From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks))
- Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response(From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks))
- Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Baseline, 2 Weeks)
- Pharmacokinetics (PK): Apparent Clearance of Abemaciclib(Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose)
- PK: Apparent Volume of Distribution of Abemaciclib(Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose)