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Recruiting Phase 2

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

NCT07368998 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 2
Started
2026-02-18
Last updated
2026-10-06

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Inavolisib →Fulvestrant →

Inavolisib: Participants will receive Inavolisib as per the schedule given in the protocol.

Fulvestrant: Participants will receive Fulvestrant as per the schedule given in the protocol.

Study summary

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation * Life expectancy of \> 6 months * Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes Exclusion Criteria: * Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis

Primary outcome measure(s)

  • Percentage of Participants With Objective Response Rate (ORR) — Up to approximately 2 years
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to approximately 2 years

Trial sites (34)

FacilityCityRegionStatus
Los Angeles Cancer Network Los Angeles California Recruiting
Cancer Specialists of North Florida Jacksonville Florida Recruiting
HCA Midwest Division Kansas City Missouri Recruiting
Astera Cancer Care East Brunswick East Brunswick New Jersey Recruiting
Instituto de Oncologia de Rosario Rosario Santa Fe Province Recruiting
Centro Oncologico Korben Ciudad Autonoma Buenos Aires Argentina Recruiting
Hospital Privado - Centro Medico de Córdoba Córdoba Argentina Recruiting
Centro Oncologico Riojano Integral (CORI) La Rioja Argentina Recruiting
Hospital Provincial del Centenario Rosario Argentina Recruiting
Centro Oncológico de Excelencia San Juan Argentina Recruiting
Blacktown Hospital Blacktown New South Wales Recruiting
Coffs Harbour Health Campus Coffs Harbour New South Wales Recruiting
Bendigo Cancer Centre Bendigo Victoria Recruiting
Sir Charles Gairdner Hospital Perth Western Australia Recruiting
Cliniques Universitaires St-Luc Brussels Belgium Recruiting
Jessa Zkh (Campus Virga Jesse) Hasselt Belgium Recruiting
UZ Leuven Gasthuisberg Leuven Belgium Recruiting
Clinique Ste-Elisabeth Namur Belgium Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara Jalisco Recruiting
RENATI INNOVATION S.A.P.I. de C.V Guadalajara Jalisco Recruiting
Centro de Infusion Tratamiento e Investigacion Oncologica S DE R Queretaro Qro Querétaro Recruiting
CENEIT Oncologicos Mexico City Mexico Recruiting
Hospital Universitari Vall d'Hebron;Oncology Barcelona Spain Recruiting
Hospital Universitario San Cecilio Granada Spain Recruiting
Hospital Universitario 12 De Octubre Madrid Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Recruiting
Bagcilar Medipol Mega Universitesi Hastanesi Bağcılar Istanbul Recruiting
Adana Baskent University Hospital Adana Turkey (Türkiye) Recruiting
Memorial Ankara Hastanesi Ankara Turkey (Türkiye) Recruiting
Medical Park Seyhan Hospital Seyhan Turkey (Türkiye) Recruiting
Blackpool Victoria Hospital Blackpool United Kingdom Recruiting
Princess Alexandra Hospital Harlow United Kingdom Recruiting
Mount Vernon Cancer Centre Northwood, Middlesex United Kingdom Recruiting
Churchill Hospital - Oxford Cancer & Haematology Centre Oxford United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07368998 on ClinicalTrials.gov ↗ ← All trials in Turkey