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Taking people in Puerto RicoPhase 2

Safety of inavolisib and fulvestrant in advanced breast cancer with diabetes

Tests the safety of inavolisib plus fulvestrant in adults with breast cancer and diabetes.

Key facts

Who runs it
Hoffmann-La Roche
Where
Dorado, Puerto RicoSee the siteAlso in 1 other country, 12 sites
Trial code
Registry title
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Starts
30 Nov 2026
Expected to end
30 Sept 2029
Type of study
Interventional
Treatments tested
  • Inavolisib
  • Fulvestrant
  • Palbociclib
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced breast cancer (HR+/HER2-, with a PIK3CA mutation) who also have type 2 diabetes and have had no earlier systemic treatment for advanced disease.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced unresectable or metastatic HR+/HER2- breast cancer with measurable disease (RECIST v1.1) and ECOG performance status 0-1
Earlier treatment
No prior systemic therapy for locally advanced unresectable or metastatic disease
Biomarker or test result
A PIK3CA mutation confirmed by the specified test. Type 2 diabetes with fasting blood glucose < 185 mg/dL (10.3 mmol/L) and HbA1c <= 8% (64 mmol/mol) on a stable diabetes regimen (no insulin short-term dosing).

Main reasons for not taking part

  • Pregnant or breastfeeding, or planning pregnancy during the study
  • Metaplastic breast cancer
  • Any history of Type 1 diabetes
  • Severe high or low blood sugar event within 6 months before starting treatment
  • Untreated or active brain (CNS) metastases, or leptomeningeal disease

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Where in Puerto Rico

Also in 1 other country, 12 sites

  • Pan American Center for Oncology Trials, LLCDorado, Puerto RicoTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Inavolisib + Fulvestrant + PalbociclibTreatment being tested

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

    Treatment: Inavolisib, Fulvestrant, and Palbociclib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Safety of inavolisib and fulvestrant in advanced breast cancer with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 November 2026