Not yet recruiting NCT07748208

A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes

Phase II Interventional Breast Cancer Diabetes Type II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Inavolisib, Fulvestrant, Palbociclib.
Who it may be relevant to: Registry conditions: Breast Cancer, Diabetes Type II. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

Overview

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

Drug Inavolisib
Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.
Drug Fulvestrant
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.
Drug Palbociclib
Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Primary outcome measures

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]

Secondary outcome measures (12)

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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07748208 · GO45322

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗