Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

Phase 3

Recruiting

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

• Registration Number: NL-OMON45049
• Lead Sponsor: BOOG Study Center (onderzoeksgroep zonder winstoogmerk)

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: 430

Inclusion Criteria

1. Histologically confirmed infiltrating breast cancer.
2. Stage II or III disease.
3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. Definitions see protocol page 14.
4. Age >=18
5. ECOG Group performance status <=1
6. LVEF >=50% measured by echocardiography, MUGA or MRI
7. No evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer.

Exclusion Criteria

1. Previous radiation therapy or chemotherapy
2. Pregnancy, breast feeding
3. Evidence of distant metastases
4. Evidence of bilateral 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>Pathologic complete response (pCR) rate at surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Recurrence-free, distant metastasis-free, breast cancer specific, and overall<br /><br>survival (time from randomization to event)<br /><br>• Percentage of conservative surgeries carried out<br /><br>• Percentage of patients with grade >2 toxicity (CTCAE v4.03)</p><br>