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

NCT07748208 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: GO45322
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• 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

Study Arms (1)

Inavolisib + Fulvestrant + Palbociclib

EXPERIMENTAL

Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.

Drug: Inavolisib; Drug: Fulvestrant; Drug: Palbociclib

Interventions

Inavolisib DRUG

Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.

Also known as: RO7113755

Inavolisib + Fulvestrant + Palbociclib

Fulvestrant DRUG

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.

Inavolisib + Fulvestrant + Palbociclib

Palbociclib DRUG

Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Inavolisib + Fulvestrant + Palbociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Breast Neoplasms; Diabetes Mellitus, Type 2

Interventions

inavolisib; Fulvestrant; palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share