drugset / Trial / NCT05306041

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

NCT05306041

Phase 2 Recruiting 170 enrolled GBG Forschungs GmbH Roche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

Timeline

Start
2023-01-02
Primary completion
2026-10
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Inavolisib Small molecule 9 mg
Background Phesgo Unknown Subcutaneous
Background Tamoxifen Small molecule 20 mg