The KATHERINE study of adjuvant trastuzumab emtansine in HER2-positive breast cancer: analysis of patients with HER2-negative residual invasive disease on re-testing

Following chemotherapy and human epidermal growth factor 2 (HER2)-targeted neoadjuvant therapy for HER2-positive early breast cancer, residual invasive breast cancer at surgery may be HER2-negative on retesting in some patients. We evaluated outcomes with T-DM1 and trastuzumab in patients randomized in the phase III KATHERINE trial based on HER2-positive central testing of the core biopsy with HER2-negative central testing on their corresponding surgical specimen. In the 70/845 (8.3%) patients with HER2-negative residual disease on retesting at surgery, there were 11 IDFS events in the 42 trastuzumab-treated patients (26.2%) and none in the 28 T-DM1-treated patients, suggesting that T-DM1 should not be withheld in this patient population.

Type: Other
Archiver: European Genome-Phenome Archive (EGA)

2 Datasets 1 Publication

Click on a Dataset ID in the table below to learn more, and to find out who to contact about access to these data

Dataset ID	Description	Technology	Samples
EGAD00001009414	Clinical data including the treatment arm, HER2 status Pre- and Post-NAT.		-
EGAD00001009415	Biomarker data including the time point of sample collection, tumor content and ERBB2 gene expression.		1

Publications	Citations
Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE. Loibl S, Huang CS, Mano MS, Mamounas EP, Geyer CE, Untch M, Thery JC, Schwaner I, Limentani S, Loman N, Lübbe K, Chang JC, Hatschek T, Tesarowski D, Song C, Lysbet de Haas S, Boulet T, Lambertini C, Wolmark N. NPJ Breast Cancer 8: 2022 106	6