A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type... | NCT07748208

NCT07748208

Overview

NCT ID: NCT07748208
Lead Sponsor: Hoffmann-La RocheINDUSTRY
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
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.
Conditions: Breast Cancer
Diabetes Type II
Interventions: Inavolisib

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Jun 15, 2029Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 40Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.Contact
global-roche-genentech-trials@gene.com

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