J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 88
- 主要终点
- Part 1: Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through disease progression or death (Estimated up to 5 years)] As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
- •If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
- •Have histologically or cytologically confirmed breast cancer
- •Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
- •Have measurable disease or non-measurable, evaluable bone disease
- •Part 1: Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Up to 1 of these prior systemic treatments may contain chemotherapy
- •Part 2: Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Individuals who are eligible are either Population 1 (P1): Endocrine sensitive newly diagnosed with advanced breast cancer (de novo) relapsed with documented evidence of progression greater than (>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or Population 2 (P2): Endocrine resistant relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor. if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.
排除标准
- •Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin.
- •Have inflammatory or metaplastic breast cancer.
- •History of leptomeningeal disease or carcinomatous meningitis.
- •Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
研究组 & 干预措施
ANASTROZOLE
干预措施: ANASTROZOLE (Drug)
FULVESTRANT
干预措施: FULVESTRANT (Drug)
EXEMESTANE
干预措施: EXEMESTANE (Drug)
LETROZOLE
干预措施: LETROZOLE (Drug)
RIBOCICLIB
干预措施: RIBOCICLIB (Drug)
TERSOLISIB, TERSOLISIB, TERSOLISIB, TERSOLISIB, TERSOLISIB
干预措施: TERSOLISIB (Drug)
to match Tersolisib (LY4064809), STX-478
干预措施: to match Tersolisib (LY4064809), STX-478 (Drug)
PALBOCICLIB
干预措施: PALBOCICLIB (Drug)
abemaciclib
干预措施: abemaciclib (Drug)
结局指标
主要结局
Part 1: Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through disease progression or death (Estimated up to 5 years)] As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Part 1: Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through disease progression or death (Estimated up to 5 years)] As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed
Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.