ABCSG 55N / AMBHER Study Details

Description of patients with HER2 positive breast cancer undergoing neoadjuvant treatment and development of a dynamic composite risk score to predict the risk of distant recurrence

Study Start: FPI 03/2023
Coordinating Investigator: Marija Balic, Graz
Sample Size:: AT: 500
Study Design:
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Primary Objective

To develop a distant recurrence (DR) risk assessment model in patients with primary HER2+ BC receiving neoadjuvant systemic treatment with dual HER2-blockade (pertuzumab and trastuzumab).

Secondary Objective(s)

To evaluate the cardiac safety of pertuzumab and trastuzumab in combination with the standard chemotherapy in neoadjuvant setting in patients with primary HER2+ BC.

Exploratory Objective(s)

Real-world (neo-)adjuvant treatment patterns

The composite risk model should help to identify the patients who can gain the greatest clinical advantage from the adjuvant administration of pertuzumab as a move towards precision medicine. It is therefore necessary to gain an understanding of the relative proportion of neoadjuvant and adjuvant treatment regimens including prescription of trastuzumab, trastuzumab biosimilars, pertuzumab, and T-DM1. Adjusted comparison should then help in gauging the potential impact of reducing subsequent cost in the metastatic setting by preventing more DRs with intensified adjuvant therapy.

Translational Objective(s)

Establishment of a biobank of HER2+ tumor tissues and respective biomarker (response) assessments.

Inclusion Criteria

  • Female and male patients ≥ 18 years.

  • Signed informed consent.

  • Histologically confirmed adenocarcinoma of the breast.

  • HER2+ disease defined as 3+ by immunohistochemistry, or 2+ by immunohistochemistry and with HER2 amplification by In Situ Hybridization (ISH).

  • Patients with confirmed uni- / bilateral breast cancer may be included if at least one lesion is HER2+.

  • Prospective patients: having received at least one dose of a neoadjuvant treatment regimen with dual HER2 blockade or scheduled to receive at least one dose of neoadjuvant treatment with dual HER2 blockade in case of patients who consented before the start of neoadjuvant therapy.

  • Retrospective patients: having received at least one dose of neoadjuvant treatment regimen with dual HER2 blockade followed by definitive surgery.

  • Anti-HER2 therapy started max. 5 years before registration.

Exclusion Criteria

  • Metastatic or locally advanced disease (without loco-regional treatment options with curative intention) at the time of diagnosis.

  • Previous cancer therapy for the same disease, other than the therapy evaluated in this NIS.

  • History of other malignancy; exception: patients who have been disease-free for 5 years or patients with a history of completely resected, non-metastatic, non-melanomatous skin cancer or successfully treated in situ carcinoma are eligible.


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