Идёт набор NCT07174336

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Фаза III С лечением Breast Neoplasms Neoplasm Metastasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LY4064809, Placebo, Ribociclib, Palbociclib.
Кому может быть актуально: Состояния в реестре: Breast Neoplasms, Neoplasm Metastasis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бельгия, Бразилия +13
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) 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.

Вмешательства

Препарат LY4064809
Administered orally
Препарат Placebo
Administered orally
Препарат Ribociclib
Administered orally
Препарат Palbociclib
Administered orally
Препарат Abemaciclib
Administered orally
Препарат Anastrozole
Administered orally
Препарат Letrozole
Administered orally
Препарат Exemestane
Administered orally
Препарат Fulvestrant
Administered intramuscular

Первичные конечные точки

(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Срок оценки: Baseline through disease progression or death (Estimated up to 5 years)]
(Part 2): Progression-Free Survival [Срок оценки: Baseline to objective progression or death due to any cause (Estimated up to 5 years)]

Вторичные конечные точки (12)

(Part 1): Disease Control Rate (DCR) [Срок оценки: Baseline through measured progressive disease (Estimated up to 5 years)]
(Part 1): Time to Response (TTR) [Срок оценки: Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)]
(Parts 1 and 2): Duration of Response (DOR) [Срок оценки: Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)]
(Part 1): PFS [Срок оценки: Baseline to objective progression or death due to any cause (Estimated up to 5 years)]
(Parts 1 and 2): Overall Survival (OS) [Срок оценки: Baseline to deaths from any cause (Estimated up to 7 years)]
(Parts 1 and 2): Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD Lasting Greater than or Equal to Six Months [Срок оценки: Baseline to disease progression or death from any cause (Estimated up to 5 years)]
(Parts 1 and 2): PK: Average Plasma Concentrations of tersolisib [Срок оценки: Baseline to last PK sample collection up to 5 months]
(Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2) [Срок оценки: Baseline to disease progression on next line of treatment or death from any cause (Estimated as up to 7 years)]
(Part 2): Progression-Free Survival (PFS) [Срок оценки: Baseline to objective progression or death from any cause (Estimated up to 5 years)]
(Part 2): Objective Response Rate (ORR) [Срок оценки: Baseline to disease progression or death from any cause (Estimated up to 5 years)]
(Part 2): Time to Chemotherapy (TTC) [Срок оценки: Baseline until the start of chemotherapy (Estimated up to 7 years)]
(Part 2): Chemotherapy-Free Survival [Срок оценки: Baseline until the start of chemotherapy or death from any cause (Estimated up to 7 years)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение