A PHASE IV, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB (PHESGO) IN INDIAN PATIENTS WITH HER2-POSITIVE BREAST CANCER
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 13
- 主要终点
- 1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale.
研究概览
简要总结
This is a Phase IV, open-label, randomized, crossover,multicenter study designed to evaluate the safety and efficacy of Phesgo inadult patients who have been diagnosed with HER2+ eBC or mBC in India.
All patients fulfilling the eligibility criteria andwilling to provide informed consent will be enrolled in the study. The estimated duration of patient enrollmentis approximately 20 months. The patientenrollment will be stratified into three cohorts according to the breast cancerstage and treatment setting. Cohort 1will include patients diagnosed with HER2+ eBC and planning to take neoadjuvantchemotherapy before surgery; Cohort 2 will include patients withnon-metastatic, adequately excised, histologically confirmed invasive HER2+ eBCand planning to take adjuvant therapy; and Cohort 3 will include patientsdiagnosed with HER2+ mBC who have not received prior anti-cancer therapy formBC. Patients will be enrolled into thethree cohorts in the ratio of 2:1:2 i.e., Cohort 1 (approximately 40% of totalenrolled population), Cohort 2 (approximately 20% of total enrolled population),and Cohort 3 (approximately 40% of total enrolled population). Patients enrolled in Cohort 1 and completingthe neoadjuvant therapy would not be enrolled in Cohort 2.
Patient’s participation in the study will include threeperiods: screening period, treatment period, and post-treatment period. Eligibility of the patients will be assessedwithin a 28‑days screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Signed Informed Consent Form Women of age ≥18 years at time of signing Informed Consent Form HER2+ breast cancer status confirmed by local laboratory before study enrollment Hormone receptor status of the primary tumor determined by local assessment.
排除标准
- •Treatment with investigational therapy within 4 weeks of enrollment Serious cardiac illness or medical conditions History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias Inadequate bone marrow function.
结局指标
主要结局
1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale.
时间窗: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale
时间窗: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
a. Phesgo in combination with chemotherapy
时间窗: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
b. Phesgo without concurrent chemotherapy
时间窗: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
3. Incidence and severity of adverse events of special interest (AESIs)
时间窗: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
次要结局
- 1 For Cohort 1 only: to evaluate total pathological complete response (tpCR)(2 For Cohort 3 only: to evaluate Overall Response Rate (ORR))