What this study is
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.
What's being tested
- Inavolisib
Intervention · DRUG
Participants will receive Inavolisib as per the schedule given in the protocol.
- Fulvestrant
Intervention · DRUG
Participants will receive Fulvestrant as per the schedule given in the protocol.
Study details
- 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
- Sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Enrolling
- 80 people
- Starts
- 2026-02-18
- Est. completion
- 2031-10-31
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (34)
34 openLos Angeles Cancer Network
Los Angeles, California, United States
RecruitingCancer Specialists of North Florida
Jacksonville, Florida, United States
RecruitingHCA Midwest Division
Kansas City, Missouri, United States
RecruitingAstera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Recruiting
30 sites outside the US
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, Argentina
RecruitingCentro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
RecruitingHospital Privado - Centro Medico de Córdoba
Córdoba, Argentina
RecruitingCentro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
RecruitingHospital Provincial del Centenario
Rosario, Argentina
RecruitingCentro Oncológico de Excelencia
San Juan, Argentina
RecruitingBlacktown Hospital
Blacktown, New South Wales, Australia
RecruitingCoffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
RecruitingBendigo Cancer Centre
Bendigo, Victoria, Australia
RecruitingSir Charles Gairdner Hospital
Perth, Western Australia, Australia
RecruitingCliniques Universitaires St-Luc
Brussels, Belgium
RecruitingJessa Zkh (Campus Virga Jesse)
Hasselt, Belgium
RecruitingUZ Leuven Gasthuisberg
Leuven, Belgium
RecruitingClinique Ste-Elisabeth
Namur, Belgium
RecruitingHospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
RecruitingRENATI INNOVATION S.A.P.I. de C.V
Guadalajara, Jalisco, Mexico
RecruitingCentro de Infusion Tratamiento e Investigacion Oncologica S DE R
Queretaro Qro, Querétaro, Mexico
RecruitingCENEIT Oncologicos
Mexico City, Mexico
RecruitingHospital Universitari Vall d'Hebron;Oncology
Barcelona, Spain
RecruitingHospital Universitario San Cecilio
Granada, Spain
RecruitingHospital Universitario 12 De Octubre
Madrid, Spain
RecruitingHospital Clinico Universitario de Valencia
Valencia, Spain
RecruitingBagcilar Medipol Mega Universitesi Hastanesi
Bağcılar, Istanbul, Turkey (Türkiye)
RecruitingAdana Baskent University Hospital
Adana, Turkey (Türkiye)
RecruitingMemorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
RecruitingMedical Park Seyhan Hospital
Seyhan, Turkey (Türkiye)
RecruitingBlackpool Victoria Hospital
Blackpool, United Kingdom
RecruitingPrincess Alexandra Hospital
Harlow, United Kingdom
RecruitingMount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
RecruitingChurchill Hospital - Oxford Cancer & Haematology Centre
Oxford, United Kingdom
Recruiting
Study team
Sponsor
Hoffmann-La Roche
Study ID WO46063
Study director
Clinical Trials
Hoffmann-La Roche
CONTACT
Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.