Breast Cancer, Diabetes Type II
Conditions
Brief summary
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.
Interventions
DRUGInavolisib
Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.
DRUGFulvestrant
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.
DRUGPalbociclib
Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing * Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease * Confirmed diagnosis of HR+/HER2- breast cancer * Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test) * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion criteria
* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Metaplastic breast cancer * Any history of Type 1 diabetes * Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment * Any history of leptomeningeal disease or carcinomatous meningitis * Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible * Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Symptomatic active lung disease * History of active bowel inflammation or active inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1 | Up to approximately 21 months |
| Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1 | Up to approximately 21 months |
| Percentage of Participants with AEs After Cycle 1 | Up to approximately 21 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1 | Up to Cycle 1 (each cycle is 28 days) |
| Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications | Up to approximately 21 months |
| Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia | 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 | 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) | 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 | Up to approximately 21 months |
| Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE | 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 | Baseline, Up to approximately 21 months |
| Objective Response Rate (ORR) | Up to approximately 21 months |
| Best Overall Response Rate (BOR) | Up to approximately 21 months |
| Duration of Response (DOR) | Up to approximately 21 months |
| Progression-Free Survival (PFS) | Up to approximately 21 months |
| Overall Survival (OS) | 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) | Baseline, up to approximately 21 months |
| Mean and Mean Change From Baseline in Role Function Score as Assessed by EORTC-IL17 | 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 | Baseline, up to approximately 21 months |
Contacts
CONTACTReference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed