Clinical Trials List
Protocol NumberJ6M-MC-JSGD
NCT Number(ClinicalTrials.gov Identfier)NCT07174336
Not yet recruiting
2025-12-08 - 2032-09-03
Phase III
Recruiting5
A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of 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)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/11
Investigators and Locations
Co-Principal Investigator
- 楊明翰 無
- WEI-LI MA 無
- 林季宏 無
- MING-YANG WANG 無
- YEN-SHEN LU 無
- 林柏翰 無
- 羅喬 無
- 謝正彥 無
- 李佳真 無
- 黃柏翔 無
- Wei-Wu Chen 無
- 陳怡君 無
- 陳怡君 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Yu Liu 無
- 邱仁輝 無
- Jiun-I Lai 無
- Ta-Chung Chao 無
- 林燕淑 無
- 陳彥蓁 無
- 賴亦貞 無
- Chi-Cheng Huang 無
- 馮晉榮 無
- Yi-Fang Tsai 無
- 鄭涵方 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊捷儒 無
- 林慈恩 無
- Huey-En Tzeng 無
- Kuan-Der Lee 無
- 王國鐘 無
- 劉佳樺 無
- 楊陽生 無
- ZHENG-WEI ZHOU 無
- I-Chen Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Breast Neoplasms
Objectives
這項試驗的目的是評估將Tersolisib (LY4064809/STX-478)加入其他抗癌藥物作為晚期荷爾蒙受體陽性(HR+)/人類表皮因子生長受體2陰性(HER2-)乳癌的首次治療的療效和安全性。只要此藥對癌症有效且沒有無法忍受的副作用，參與者就可以繼續參加這項試驗。
Test Drug
錠劑
Active Ingredient
LY4064809/STX-478
Dosage Form
110
Dosage
mg
Endpoints
第一部分：找出用於第3期的LY4064809最佳劑量，方式為對於各個隨機分配之劑量濃度組中帶有PIK3CA突變的HR+、HER2- aBC參與者，評估不同劑量濃度的LY4064809與CDK4/6抑制劑和內分泌療法併用時的安全性、PK和抗腫瘤活性
第二部分：比較LY4064809與CDK4/6抑制劑和內分泌療法併用(A組)以及安慰劑與CDK4/6抑制劑和內分泌療法併用(B組)時，對於HR+、HER2-、帶有PIK3CA突變、不曾接受晚期乳癌治療之晚期乳癌參與者的療效
第二部分：比較LY4064809與CDK4/6抑制劑和內分泌療法併用(A組)以及安慰劑與CDK4/6抑制劑和內分泌療法併用(B組)時，對於HR+、HER2-、帶有PIK3CA突變、不曾接受晚期乳癌治療之晚期乳癌參與者的療效
Inclution Criteria
Inclusion Criteria:
Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
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, defined as individuals with
locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
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)
participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET
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.
Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
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, defined as individuals with
locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
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)
participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET
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.
Exclusion Criteria
Exclusion Criteria:
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.
Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams [mg] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.
Have active bacterial or fungal infection that is not recovered at randomization.
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.
Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams [mg] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.
Have active bacterial or fungal infection that is not recovered at randomization.
The Estimated Number of Participants
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Taiwan
65 participants
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Global
920 participants
