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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Inavolisib
  • Fulvestrant
  • Palbociclib

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators