CTRI/2025/04/084336尚未招募3 期
An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc
- 入组人数
- 1,020
- 试验地点
- 11
- 主要终点
- Progression Free Survival (PFS) by BICR: Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer:
- HR-positive (breast cancer cells that need estrogen or progesterone to grow)
- HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
- locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
- who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator’s choice of treatment plus letrozole.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- •Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor.
- •Documented HER2-negative tumor.
- •Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
- •Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
排除标准
- •In visceral crisis at risk of immediately life-threatening complications in the short term.
- •Current or past history of central nervous system metastases.
- •Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- •Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- •Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
结局指标
主要结局
Progression Free Survival (PFS) by BICR: Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
时间窗: Upto 13 years
次要结局
- Overall Survival (OS): Time from the date of randomization to the date of death due to any cause(Up to approximately 13 years)
- Progression Free Survival (PFS) by Investigator: Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first(Up to approximately 4 years)
- Estimated mean change from baseline in EORTC QLQ C30(Up to approximately 4 years)
- Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)(Up to approximately 4 years)
- Mean change from baseline of ctDNA(Up to approximately 4 years)
- OR by BICR & by investigator: Time from randomization date (every 8 weeks during the first 48 weeks & then every 12 weeks) to the date of progression OR death whichever occurs first
- Duration of Response (DoR) by BICR & by investigator: Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first(Up to approximately 4 years)
- Incidence of treatment emergent treatment related adverse events (AE): Incidence & severity of AEs graded according to the NCI CTCAE v5.0(Up to 13 years.)
- Estimated mean change from baseline in BPI-SF(Up to approximately 4 years)
- Estimated mean change from baseline in EQ-5D-5L(Up to approximately 4 years)
研究者
研究点 (11)
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