CTRI/2024/07/069956进行中（未招募）3 期
An Interventional, Open-label, randomized, multicentre Phase 3 study of PF-07220060 plus fulvestrant compared to investigators choice of therapy in participants over 18 years of age with hormone receptor-positive, HER2-Negative advanced/metastatic breast cancer whose disease progressed after prior CDK 4/6 inhibitor based therapy.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 510
- 试验地点
- 10
- 主要终点
- (1) Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor’s choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.
This study is seeking female and male participants who:
- are 18 years of age or older;
- are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;
- have advanced or metastatic breast cancer after taking other treatments before this study;
- have not taken or need to take medications that are not allowed by the study protocol;
- do not have any medical or mental conditions that may increase the risk of study participation.
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor’s choice of treatment which can either be:
- Fulvestrant alone taken as shot into the muscle.
- Everolimus along with exemestane taken once daily by mouth.
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor’s choice of treatment. This will help decide if the study medicine is safe and effective.
Participants will receive study treatment and/or will be in the study until:
- imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.
- the study doctor thinks the participant is no longer benefitting from the study medicine.
- has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.
- the participant chooses to stop taking part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 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.
- •Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
- •Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
- •Measurable disease or non-measurable bone only disease as defined by RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than equal to 2.
排除标准
- •Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- •In visceral crisis at risk of immediately life-threatening complications in the short term.
- •Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- •Prior treatment with any of the following:.
- •Everolimus or investigational anti-cancer agents in any setting.
- •Prior chemotherapy in the advanced setting.
- •Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5 diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
- •Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
结局指标
主要结局
(1) Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: (1) From Initiation up to 2 years | (2) Baseline up to 12 months
(2) Number of Participants with Objective Response (OR)
时间窗: (1) From Initiation up to 2 years | (2) Baseline up to 12 months
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 5 years)
- PFS as defined by investigator(Time from the date of randomization up to approximately 2 years)
- OR by BICR & by investigator per RECIST v1.1(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 (up to approximately 2 years))
- Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) & by investigator per RECIST v1.1(From the date of the first objective response (every 8 weeks during the first 48 weeks & then every 12 week) up to approximately 2 years.)
- Number of Participants With Clinical Benefit Response (CBR) by BICR & by investigator per RECIST v1.1(From randomization date (every 8 weeks during the first 48 weeks & then every 12 weeks) up to approximately 2 years)
- Number or Patients with Adverse Events (AEs) by Type(From screening until 28 days after the last dose, to approximately 3 years)
- Number or Patients with AEs by Incidence(From screening until 28 days after the last dose, to approximately 3 years)
- Number or Patients with AEs by Seriousness(From screening until 28 days after the last dose, to approximately 3 years)
- Number or Patients with AEs by relationship to study interventions(From screening until 28 days after the last dose, to approximately 3 years)
- Number of Participants With Abnormal Electrocardiogram (ECG)(From baseline to approximately 2 years)
- Number of Participants With Laboratory Test Abnormalities(From screening until 28 days after the last dose to approximately 2 years)
- EQ-5D-5L(Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days)
- EORTC QLQ(Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days)
- EORTC QLQ Breast Cancer Module 23 (BR23)(Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days)
- Ctrough of PF-07220060(Cycle 1 (Day 15), Cycle 2 (Day 1), & Cycle 3 (Day 1). Each Cycle is 28 days)
研究者
研究点 (10)
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