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A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
420 patients around the world
Available in Brazil, United States, Mexico, Argentina, Belgium, Spain
The drug-drug interaction (DDI) substudy will evaluate the impact of repeat doses of inavolisib (coadministered with fulvestrant) on single-dose pharmacokinetics of sensitive CYP450 enzyme substrates (midazolam, omeprazole and bupropion) in participants with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after CDK4/6 inhibitor (CDK4/6i) in combination with endocrine therapy (ET).
Enrollment for the substudy is now open to recruitment.
Hoffmann-La Roche
18Research sites
420Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intentDocumented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelinesConfirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified testDisease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowedMeasurable 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 guidelinesEastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2Life expectancy of > 6 monthsAdequate hematologic and organ function prior to initiation of study treatment
- Metaplastic breast cancerPrior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathwayParticipant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic diseasePregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatmentType 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetesInability or unwillingness to swallow pillsMalabsorption syndrome or other condition that would interfere with enteral absorptionAny history of leptomeningeal disease or carcinomatous meningitisKnown and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteriaKnown active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that conditionActive inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eyeRequirement for daily supplemental oxygenSymptomatic active lung disease, including pneumonitisHistory of or active inflammatory bowel diseaseAny active bowel inflammationClinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosisParticipants with known human immunodeficiency virus infection that meet specific criteriaInvestigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longerHistory of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrenceChronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic diseaseAllergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulationsHistory of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic SymptomsActive ongoing osteonecrosis of the jaw
Sites
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Instituto Multidisciplinario de Oncología - CIC - Clínica Viedma, Río Negro.
Recruiting
Centro Oncológico Korben
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
CIOC- Centro de Investigación Oncológica Clínica - Rosario
Recruiting
Sanatorio Parque - Rosario
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Faculdade de Medicina de São José do Rio Preto-SP (FAMERP) - Hospital de Base (HB)
Recruiting
StudyINAVO121
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05646862
