A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes

Официальное название

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

Обзор

This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.

Вмешательства

• Препарат Inavolisib
  Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.
• Препарат Fulvestrant
  Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.
• Препарат Palbociclib
  Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Первичные конечные точки

• Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1 [Срок оценки: Up to approximately 21 months]
• Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1 [Срок оценки: Up to approximately 21 months]
• Percentage of Participants with AEs After Cycle 1 [Срок оценки: Up to approximately 21 months]

Вторичные конечные точки (12)

• Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1 [Срок оценки: Up to Cycle 1 (each cycle is 28 days)]
• Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications [Срок оценки: Up to approximately 21 months]
• Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia [Срок оценки: Up to approximately 21 months]
• Percentage of Participants With Return of Hemoglobin A1c or Glycated Hemoglobin (HbA1c) to Within 10% of Baseline Within 90 Days After Inavolisib Discontinuation [Срок оценки: Up to approximately 21 months]
• Number of Participants Reporting Presence,Frequency,Severity,&/or Degree of Interference with Daily Function of Selected Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for AEs (PRO-CTCAE) [Срок оценки: Up to approximately 21 months]
• Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire [Срок оценки: Up to approximately 21 months]
• Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE [Срок оценки: Baseline, Up to approximately 21 months]
• Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G General Population, Question 5 (GP5) Item [Срок оценки: Baseline, Up to approximately 21 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 21 months]
• Best Overall Response Rate (BOR) [Срок оценки: Up to approximately 21 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 21 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 21 months]

Критерии участия

Критерии включения

• Type 2 diabetes with laboratory fasting blood glucose < 185 milligrams per deciliter (mg/dL) and HbA1c <= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
• Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
• Confirmed diagnosis of HR+/HER2- breast cancer
• Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
• Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Критерии исключения

• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
• Metaplastic breast cancer
• Any history of Type 1 diabetes
• Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
• Any history of leptomeningeal disease or carcinomatous meningitis
• Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
• Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
• Symptomatic active lung disease
• History of active bowel inflammation or active inflammatory bowel disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07748208 · GO45322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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