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NOT YET RECRUITING
NCT07748208
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-01

Completion Date

2029-09-30

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Inavolisib

Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.

DRUG

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.

DRUG

Palbociclib

Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.