This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.
Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.
Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1
Time frame: Up to approximately 21 months
Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1
Time frame: Up to approximately 21 months
Percentage of Participants with AEs After Cycle 1
Time frame: Up to approximately 21 months
Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1
Time frame: Up to Cycle 1 (each cycle is 28 days)
Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications
Time frame: Up to approximately 21 months
Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia
Time frame: Up to approximately 21 months
Percentage of Participants With Return of Hemoglobin A1c or Glycated Hemoglobin (HbA1c) to Within 10% of Baseline Within 90 Days After Inavolisib Discontinuation
Time frame: Up to approximately 21 months
Number of Participants Reporting Presence,Frequency,Severity,&/or Degree of Interference with Daily Function of Selected Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for AEs (PRO-CTCAE)
Time frame: Up to approximately 21 months
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.
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Time frame: Up to approximately 21 months
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline, Up to approximately 21 months
Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G General Population, Question 5 (GP5) Item
Time frame: Baseline, Up to approximately 21 months
Objective Response Rate (ORR)
Time frame: Up to approximately 21 months
Best Overall Response Rate (BOR)
Time frame: Up to approximately 21 months
Duration of Response (DOR)
Time frame: Up to approximately 21 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 21 months
Overall Survival (OS)
Time frame: Up to approximately 21 months
Mean and Mean Change From Baseline in Physical Function Score as Assessed by European Organisation for Research and Treatment of Cancer Item Library 17 (EORTC-IL17)
Time frame: Baseline, up to approximately 21 months
Mean and Mean Change From Baseline in Role Function Score as Assessed by EORTC-IL17
Time frame: Baseline, up to approximately 21 months
Mean and Mean Change From Baseline in Health-Related Quality of Life (HRQoL) Score as Assessed by EORTC-IL17
Time frame: Baseline, up to approximately 21 months