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

NCT07368998 · Hoffmann-La Roche
In plain English

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Official title
A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
About this study
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
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
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-18
Estimated completion: 2031-10-31
Last updated: 2026-07-07
Interventions
Drug: InavolisibDrug: Fulvestrant
Primary outcomes
  • 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)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (30)
Los Angeles Cancer NetworkRecruiting
Los Angeles, California, United States
Astera Cancer Care East BrunswickRecruiting
East Brunswick, New Jersey, United States
Instituto de Oncologia de RosarioRecruiting
Rosario, Santa Fe Province, Argentina
Centro Oncologico KorbenRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Hospital Privado - Centro Medico de CórdobaRecruiting
Córdoba, Argentina
Centro Oncologico Riojano Integral (CORI)Recruiting
La Rioja, Argentina
Hospital Provincial del CentenarioRecruiting
Rosario, Argentina
Centro Oncológico de ExcelenciaRecruiting
San Juan, Argentina
Blacktown HospitalRecruiting
Blacktown, New South Wales, Australia
Coffs Harbour Health CampusRecruiting
Coffs Harbour, New South Wales, Australia
Bendigo Cancer CentreRecruiting
Bendigo, Victoria, Australia
Cliniques Universitaires St-LucRecruiting
Brussels, Belgium
Jessa Zkh (Campus Virga Jesse)Recruiting
Hasselt, Belgium
UZ Leuven GasthuisbergRecruiting
Leuven, Belgium
Clinique Ste-ElisabethRecruiting
Namur, Belgium
Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
Guadalajara, Jalisco, Mexico
RENATI INNOVATION S.A.P.I. de C.VRecruiting
Guadalajara, Jalisco, Mexico
Centro de Infusion Tratamiento e Investigacion Oncologica S DE RRecruiting
Queretaro Qro, Querétaro, Mexico
CENEIT OncologicosRecruiting
Mexico City, Mexico
Hospital Universitari Vall d'Hebron;OncologyRecruiting
Barcelona, Spain
Hospital Universitario San CecilioRecruiting
Granada, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Bagcilar Medipol Mega Universitesi HastanesiRecruiting
Bağcılar, Istanbul, Turkey (Türkiye)
Adana Baskent University HospitalRecruiting
Adana, Turkey (Türkiye)
Memorial Ankara HastanesiRecruiting
Ankara, Turkey (Türkiye)
Medical Park Seyhan HospitalRecruiting
Seyhan, Turkey (Türkiye)
Blackpool Victoria HospitalRecruiting
Blackpool, United Kingdom
Princess Alexandra HospitalRecruiting
Harlow, United Kingdom
Mount Vernon Cancer CentreRecruiting
Northwood, Middlesex, United Kingdom
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer · TrialPath