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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

RecruitingPhase 2Ages 18 Years - anyAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Inavolisib
  • Fulvestrant
  • Palbociclib
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Where

10 sites
MedStar Washington Hosp Center
Washington D.C., United States
Grady Memorial Hospital
Atlanta, United States
Emory University Hospital Midtown
Atlanta, United States
Emory University Hospital
Atlanta, United States
Nebraska Cancer Specialists St Francis - Grand Island
Grand Island, United States
Nebraska Cancer Specialists
Omaha, United States
NYU Langone Hospital Long Island Clinical Research
Mineola, United States
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St
New York, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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