Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518026-32-00

Acronym

FM-17-B01

Enrollment

646

Registered

2024-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Breast Cancer

Brief summary

Event Free Survival (EFS)

Detailed description

Pathological Complete Response (pCR), Relationship between pCR and EFS, Clinical Overall Response (cOR) at the end of neo-adjuvant treatment, Disease-Free Survival (DFS), Distant Event Free Survival, Overall Survival

Interventions

DRUGKadcyla 160 mg powder for concentrate for solution for infusion.

DRUGPerjeta 420 mg concentrate for solution for infusion

DRUGPhesgo 600 mg/600 mg solution for injection

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGPhesgo 1200 mg/600 mg solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event Free Survival (EFS)	—

Secondary

Measure	Time frame
Pathological Complete Response (pCR), Relationship between pCR and EFS, Clinical Overall Response (cOR) at the end of neo-adjuvant treatment, Disease-Free Survival (DFS), Distant Event Free Survival, Overall Survival	—

Countries

Austria, Belgium, Germany, Italy, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026