NIPH Clinical Trials Search

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER
Date of first enrollment	16/01/2026
Target sample size	450
Countries of recruitment	United States,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Puerto Rico,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,,Japan
Study type	Interventional
Intervention(s)	Inavolisib: Inavolisib will be administered orally 9/6mg QD. Placebo: Placebo will be administered orally QD. Palbociclib: Administer the standard dose orally. Letrozole: Administer the standard dose orally.

Outcome(s)

Primary Outcome

efficacy Progression-Free Survival (PFS)

Secondary Outcome

safety, efficacy Overall Survival (OS) Investigator-assessed Objective Response Rate (ORR) Investigator-assessed Duration of Response (DOR) Investigator-assessed Clinical Benefit Rate (CBR) Time to Confirmed Deterioration (TTCD) in Pain TTCD in Physical Function TTCD in Role Function TTCD in Global Health Status Percentage of Participants with Adverse Events Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G) Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Women or men with histologically or cytologically confirmed carcinoma of the breast -Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines -Documented HER2-negative tumor according to ASCO/CAP guidelines -De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment -Participants who have bilateral breast cancers which are both HR-positive and HER2-negative -Confirmation of biomarker eligibility -Consent to provide fresh or archival tumor tissue specimen -Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclude criteria	-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 prior systemic therapy for locally advanced unresectable or metastatic breast cancer -Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes -Any history of leptomeningeal disease or carcinomatous meningitis -Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible -Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye -Symptomatic active lung disease -History of or active inflammatory bowel disease -Any active bowel inflammation -Prior hematopoietic stem cell or bone marrow transplantation -Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment