Abstract PS7-61: The Neat-HER Virtual Registry: Results on HER2+ breast cancer patients receiving neratinib as extended adjuvant therapy
Authors: Rugo Hope S , Vidal Gregory A , Oestreicher Nina , Lalla Deepa , Hanson Gillian , Zhong Yi , Tripathy Debu 
Published: February 2021

Background: While data from traditional registries are typically limited to patients treated at study sites, virtual registries can enroll a broader real-world population. Neat-HER is a U.S.-based virtual registry pilot through PicnicHealth that is enrolling patients with HER2+ breast cancer receiving neratinib as extended adjuvant therapy.

Methods: Neat-HER evaluates the feasibility of enrolling patients and answering research questions using a novel electronic platform. Eligibility includes receipt of neratinib in the extended adjuvant setting, signed informed consent for medical record retrieval/data abstraction and age &gt;18 years. Patients who do not complete enrollment procedures, are participating in a clinical trial or have metastatic disease are excluded. Patients are recruited through multiple mechanisms including private social media groups, treating clinicians and patients enrolled in the Puma Texting Program. Patient health records for breast cancer-related treatment are collected from time of diagnosis to 1-year post-enrollment in the registry. Research questions focus on patient and tumor characteristics, receipt of therapy (e.g. radiotherapy, adjuvant therapy), neratinib duration, and diarrhea prophylaxis.

Results: 22 patients with HER2+ early-stage breast cancer who received neratinib as extended adjuvant therapy have been enrolled in this registry study since December 2018. Median age was 51 years, with 77% of patients self-identifying as white. 73% of patients had hormone receptor-positive (ER/PR) disease and 73% of patients had node-positive disease. Prior HER2-targeted adjuvant therapy regimens were as follows: trastuzumab with paclitaxel (9%); trastuzumab/pertuzumab in combination (91%; all but 1 of whom also received docetaxel). 16 patients (73%) completed 12 months of neratinib treatment; 3 patients (14%) discontinued treatment early; 3 patients (14%) were still ongoing at the time of data cutoff. 6 patients (27%) had dose holds and 3 patients (14%) had a dose reduction during the course of neratinib treatment. 21 patients (95%) had diarrhea prophylaxis discussed prior to the start of neratinib treatment.

Conclusions: Neat-HER provides useful information on patient/tumor characteristics and treatment patterns in a real-world cohort receiving extended adjuvant neratinib. Preliminary results show that this pilot virtual registry is a feasible and efficient modality to collect important data on descriptive characteristics and treatment patterns for a patient population derived from real-world practice settings. Validation of this method is needed and could be used to evaluate important trends such as the frequency of neoadjuvant therapy and associated outcomes in a larger population.

Citation Format: Hope S Rugo, Gregory A Vidal, Nina Oestreicher, Deepa Lalla, Gillian Hanson, Yi Zhong, Debu Tripathy. The Neat-HER Virtual Registry: Results on HER2+ breast cancer patients receiving neratinib as extended adjuvant therapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-61.