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

Cancer
Breast Cancer
Metabolic Disorder
Type 2 Diabetes Mellitus

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Study Identifier NCT07748208, GO45322

Condition Breast Cancer, Diabetes Type II

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

Study 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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com