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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Participants will receive Inavolisib as per the schedule given in the protocol.
Participants will receive Fulvestrant as per the schedule given in the protocol.
Percentage of Participants With Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to Response (TTR)
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Percentage of Participants With Treatment Discontinuation due to Adverse Events
Time frame: Up to approximately 2 years
Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to approximately 2 years
Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382
Time frame: Up to approximately 2 years
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time frame: Up to approximately 2 years
Reference Study ID Number: WO46063 https://forpatients.roche.com/
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Los Angeles Cancer Network
Los Angeles, California, United States
RECRUITINGAstera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
RECRUITINGInstituto 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
RECRUITINGHospital Provincial del Centenario
Rosario, Argentina
RECRUITINGBlacktown Hospital
Blacktown, New South Wales, Australia
RECRUITINGBendigo Cancer Centre
Bendigo, Victoria, Australia
RECRUITINGCliniques Universitaires St-Luc
Brussels, Belgium
RECRUITINGJessa Zkh (Campus Virga Jesse)
Hasselt, Belgium
RECRUITING...and 16 more locations
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline, Up to approximately 2 years
Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382
Time frame: Baseline, Up to approximately 2 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time frame: Baseline, Up to approximately 2 years