NCT07164976招募中1 期
Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Phase 1b part: Dose Limiting Toxicity
研究概览
简要总结
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..
Study Design and Endpoints: The trial is structured into two parts:
- Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
- Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer.
- •Hormone receptor-positive (ER positive and/or PgR positive) and HER2-negative disease:
- •ER positive: ≥1% positive cells or Allred score ≥
- •PgR positive: ≥1% positive cells or Allred score ≥
- •HER2 negative: IHC 0, 1+, or 2+ with no ISH amplification.
- •Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV).
- •Age ≥18 years at registration.
- •ECOG Performance Status of 0-1.
排除标准
- •Symptomatic visceral metastases or deemed unsuitable for endocrine therapy.
- •Prior endocrine therapy or chemotherapy for metastatic/recurrent disease.
- •Prior CDK4/6 inhibitor exposure (perioperative or metastatic setting).
- •Adjuvant endocrine therapy within 35 days before study start.
- •Active malignancy other than allowed exceptions (e.g., resected skin cancers, ≥5-year disease-free cancers).
- •Hypersensitivity to ribociclib, anastrozole, or their components (including soy/peanut allergy, sugar intolerances).
研究组 & 干预措施
phase 1b cohort 1
Experimental
phase 1b cohort 1
干预措施: Ribociclib 400mg (Drug)
phase 1b cohort 2
Experimental
phase 1b cohort 2
干预措施: Ribociclib 600mg (Drug)
phase 2 part
Experimental
干预措施: Ribociclib 600mg (Drug)
结局指标
主要结局
Phase 1b part: Dose Limiting Toxicity
时间窗: From enrollment to the end of treatment at 4 weeks
Phase 2 part: Overall response rate
时间窗: From enrollment to the end of treatment at 24 weeks
次要结局
- Phase 1b part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From enrollment to the end of treatment at 4 weeks)
- Phase 1b part: Peak Plasma Concentration (Cmax)(From enrollment to the end of treatment at 4 weeks)
- Phase 2 part: Overall Response Rate(From enrollment to the end of treatment at 24 weeks)
- Phase 2 part: PFS(Time Frame: From enrollment to the end of treatment at 24 weeks)
- Phase 2 part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From enrollment to the end of treatment at 24 weeks)
研究者
Kazuki Nozawa
Principal Investigator
Nagoya City University
研究点 (1)
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