NCT07347600

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

A Prospective Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

Conditions

• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
DRUG	Palbociclib	Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
DRUG	Fulvestrant	Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Timeline

• Start date: 2026-01-21
• Primary completion: 2028-12-31
• Completion: 2029-09-09
• First posted: 2026-01-16
• Last updated: 2026-03-20

Locations

9 sites across 1 country: China