Recruiting Phase 3 2024-518026-32-00

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

Phase 3 – large-scale trial before approval

Conditions: Invasive Breast Cancer

Sponsor: Fondazione Michelangelo

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Overview

Trial status: Authorised 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 Event Free Survival (EFS)

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

Who can participate

Age group: 18-64 years, 65+ years Gender: Female Target enrollment: 646 participants

Interventions

Phesgo 1200 mg/600 mg solution for injection

Drug

Perjeta 420 mg concentrate for solution for infusion

Drug

Kadcyla 160 mg powder for concentrate for solution for infusion.

Drug

Tecentriq 1 200 mg concentrate for solution for infusion

Drug

Phesgo 600 mg/600 mg solution for injection

Drug

Locations 6

Austria (1)

Belgium (1)

Germany (1)

Italy (1)

Romania (1)

Spain (1)

Status

Recruiting

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

21.11.2024

Registry ID

2024-518026-32-00

Source

euclinicaltrials.eu

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