Cancer
Conditions
Interventions
Maintenance Therapy Inavolisib plus Phesgo
Maintenance Therapy Placebo plus Phesgo
Sponsors
Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection - Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity - Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status - Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months - LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) - Adequate hematologic and organ function prior to initiation of study treatment
Exclusion criteria
Exclusion criteria: - Prior treatment in the 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 pathway - Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy - History or active inflammatory bowel disease - Disease progression within 6 months of receiving any HER2-targeted therapy - Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes - Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis - Symptomatic active lung disease, including pneumonitis or interstitial lung disease - Any history of leptomeningeal disease or carcinomatous meningitis - Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1 - Any 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 condition - Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Progression-Free Survival (PFS) [ Time Frame: Up to approximately 40 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) [ 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. ] 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) - 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. ] | — |
Countries
Kenya, Uganda
Contacts
Public ContactFaith Wanjau
Clinical Operations Lead
Outcome results
None listed