Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: the TRAIN-3 study.

Phase 2

Recruiting

• Conditions: breast cancer; HER2 positive breast cancer; 10006291

• Registration Number: NL-OMON54506
• Lead Sponsor: BOOG Study Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 462

Inclusion Criteria

1. Histologically confirmed primary infiltrating breast cancer.
2. Stage II or III disease.
3. Overexpression and/or amplification of HER2 in an invasive component of the
core biopsy.
4. Age <:18
5. ECOG Group performance status
6. LVEF >50% measured by echocardiography, MRI or MUGA
7. Known HR-status ( in percentages)

Exclusion Criteria

1. Previous chemotherapy
2. Pregnancy or breastfeeding
3. Evidence of distant metastases
4. Evidence of bilateraal infiltrating breast cancer
5. Concurrent anti-cancer treatment or another investigational drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Event-free survival (EFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Overall survival<br />• Pathologic complete response in breast and axilla<br />• Radiologic complete response<br />• Number over neoadjuvant chemotherapy cycles administered<br />• Safety and exploratory translational outcomes</p>