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 (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1,035
- 试验地点
- 867
- 主要终点
- Progression Free Survival (PFS) by BICR
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
- 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
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Arm A
PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
干预措施: PF-07220060 (Drug)
Arm B
Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
干预措施: palbociclib (Drug)
Arm A
PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
干预措施: letrozole (Drug)
Arm B
Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
干预措施: ribociclib (Drug)
Arm B
Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
干预措施: letrozole (Drug)
Arm B
Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
干预措施: abemaciclib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by BICR
时间窗: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
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
次要结局
- OR by BICR and by investigator(From randomization to progression or death whichever occurs first (up to approximately 4 years))
- Overall Survival (OS)(From the date of randomization until death due to any cause (up to approximately 13 years).)
- Progression Free Survival (PFS) by Investigator(From the date of randomization until disease progression or death due to any cause (up to approximately 4 years))
- Duration of Response (DoR) by BICR and by investigator(From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years))
- Incidence of treatment emergent treatment related adverse events (AE)(Duration of the study approximately up to 13 years.)
- Incidence of treatment emergent treatment related serious adverse events(Duration of the study approximately up to 13 years.)
- Estimated mean change from baseline in EORTC QLQ C30(Baseline to end of treatment (up to approximately 4 years))
- Estimated mean change from baseline in BPI-SF(Baseline to end of treatment (up to approximately 4 years))
- Estimated mean change from baseline in EQ-5D-5L(Baseline to end of treatment (up to approximately 4 years))
- Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)(Baseline to end of treatment (up to approximately 4 years))
- Mean change from baseline of ctDNA(Baseline to end of treatment (up to approximately 4 years))