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NCT07368998PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

2/18/2026

Completion Date

10/31/2031

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Inavolisib

DRUG

Fulvestrant

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Conditions

Breast Cancer

Locations

Los Angeles Cancer Network

Los Angeles, California 90017-4803

United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey 08816

United States

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province S2000KPG

Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE

Argentina

Hospital Privado - Centro Medico de Córdoba

Córdoba, 5016

Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE

Argentina

Hospital Provincial del Centenario

Rosario, S2002KDS

Argentina

Centro Oncológico de Excelencia

San Juan, J5402BGA

Argentina

Blacktown Hospital

Blacktown, New South Wales NSW 2148

Australia

Coffs Harbour Health Campus

Coffs Harbour, New South Wales 2450

Australia

Bendigo Cancer Centre

Bendigo, Victoria 3550

Australia

Cliniques Universitaires St-Luc

Brussels, 1200

Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500

Belgium

UZ Leuven Gasthuisberg

Leuven, 3000

Belgium

Clinique Ste-Elisabeth

Namur, 5000

Belgium

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco 44280

Mexico

RENATI INNOVATION S.A.P.I. de C.V

Guadalajara, Jalisco 44680

Mexico

Centro de Infusion Tratamiento e Investigacion Oncologica S DE R

Queretaro Qro, Querétaro 76090

Mexico

CENEIT Oncologicos

Mexico City, 03100

Mexico

Hospital Universitari Vall d'Hebron;Oncology

Barcelona, 08035

Spain

Hospital Universitario San Cecilio

Granada, 18016

Spain

Hospital Universitario 12 De Octubre

Madrid, 28041

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Bagcilar Medipol Mega Universitesi Hastanesi

Bağcılar, Istanbul 34214

Turkey (Türkiye)

Adana Baskent University Hospital

Adana, 01120

Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, 06520

Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan,

Turkey (Türkiye)

Blackpool Victoria Hospital

Blackpool, FY3 8NR

United Kingdom

Princess Alexandra Hospital

Harlow, CM20 1QX

United Kingdom

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN

United Kingdom