ABCSG 55N /AMBHER
Status: Treatment Phase & Follow-up
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 30.03.2023 |
| Coordinating Investigator: | Marija Balic, Pittsburgh |
| Sample Size: | 501 (national) |
Description and status:
This non-interventional, single-arm, multicenter study with an ambispective design includes patients with early-stage HER2-positive breast cancer who have received neoadjuvant therapy with dual HER2 blockade consisting of pertuzumab and trastuzumab. Patients are assigned to either the retrospective or the prospective cohort.
The objectives of the study are to develop a dynamic predictive model to estimate the risk of distant recurrence and to identify those patients who could benefit most from adjuvant pertuzumab therapy. In doing so, the study makes an important contribution to the further development of precision medicine and individualized treatment planning. In addition, the study investigates the cardiac safety of the combination of pertuzumab and trastuzumab with standard chemotherapy in the neoadjuvant setting. Complementary translational biomarker analyses are performed based on an established biobank to further characterize potential prognostic and predictive factors.
With the Last Patient In (LPI) on August 3, 2026, a total of 501 patients were enrolled in the study. Of these, 276 patients (55%) were in the retrospective cohort and 225 patients (45%) were in the prospective cohort. With the participation of a total of eight Austrian study centers, a comprehensive and valuable database has thus been established to support further scientific analyses.
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