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NCT07748208RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
20 Jul 2026
Start date
30 Oct 2026
Primary completion date
15 Jun 2029
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07748208

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 30 Oct 2026 to the primary completion date, 15 Jun 2029
  • 10 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Metaplastic breast cancer
  • Any history of Type 1 diabetes
  • 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

Other

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pan American Center for Oncology Trials, LLC
Coordinator of this site? Confirm its status
DoradoPuerto RicoRecruiting
Emory University Hospital Midtown
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Emory University Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Grady Memorial Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Nebraska Cancer Specialists St Francis - Grand Island
Coordinator of this site? Confirm its status
Grand IslandUnited StatesRecruiting
NYU Langone Hospital Long Island Clinical Research
Coordinator of this site? Confirm its status
MineolaUnited StatesRecruiting
West Virginia University
Coordinator of this site? Confirm its status
MorgantownUnited StatesRecruiting
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Nebraska Cancer Specialists
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
MedStar Washington Hosp Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.