This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
230
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Banner Health MD Anderson AZ
Gilbert, Arizona, United States
RECRUITINGDisney Family Cancer Center
Burbank, California, United States
RECRUITINGCity of Hope
Corona, California, United States
RECRUITINGCity of Hope Comprehensive Cancer Center
Duarte, California, United States
Investigator-Assessed Progression-Free Survival (PFS)
Time frame: Up to approximately 40 months
Overall Survival (OS)
Time frame: Up to approximately 111 months
Investigator-Assessed Objective Response Rate (ORR)
Time frame: Up to approximately 111 months
Investigator-Assessed Duration of Response (DOR)
Time frame: Up to approximately 111 months
Investigator-Assessed Clinical Benefit Rate (CBR)
Time frame: Up to approximately 111 months
Investigator-Assessed PFS2
Time frame: Up to approximately 111 months
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Time frame: Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days.
Percentage of Participants with Adverse Events
Time frame: Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.
Plasma Concentration of Inavolisib at Specified Timepoints
Time frame: Day 1 of Cycles 1 and 4. Each cycle is 21 days.
Reference Study ID Number: WO44263 https://forpatients.roche.com/
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
City of Hope at Irvine Lennar
Irvine, California, United States
RECRUITINGEllison Institute of Technology
Los Angeles, California, United States
RECRUITINGGeorgetown Uni Hospital
Washington D.C., District of Columbia, United States
RECRUITINGMedstar Research Institute
Hyattsville, Maryland, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITING...and 174 more locations