A brief background discussion:

The OncotypeDX® multigene assay is recommended by several international guidelines as a predictive and prognostic factor for HR+/HER2- early breast cancer (EBC). Several trials have shown the necessity of OncotypeDX® Recurrence Score (RS) as a decision tool for HR+/HER2- EBC with 0-3 lymph nodes (LN) involved. At present, though, only limited data from the routine setting are available on the impact of treatment decision making process based on the usage of classical proliferation marker Ki67 with or without knowing the individual RS prior and after a treatment decision from a multidisciplinary tumor board (MTB) for the decision making of the adjuvant therapy of EBC. The Oncotype DX® assay is still not reimbursed by every insurance, therefore we expect that this registry will have an impact on reimbursement in Germany.

Trial design:

The OncotypeDX®-REMAR(Rhein-Main-Registry) study is a prospective, non-interventional, multicenter and non-randomized, study. 13 certified breast cancer (BC) centers in the Rhine-Main region in Germany participate. The sponsor of this trial is the AGAPLESION, Markus Hospital Frankfurt, Genomic Health provides the financial support.

After registration, the patient´s case will be discussed in the respective institution's MTB, before and after the RS result. The adjuvant treatment will be recommended based on available clinical and histopathological data according to the guidelines and the RS result. After each meeting, the physician and patient will fill in a questionnaire. In addition to the local determination of Ki67 and nuclear grading, a central pathology assessment of these two markers will be provided in a blinded fashion. Only the sponsor has access to these results. Consequently, this independent test has no influence both on the local histopathology result and on the recommended treatment.

Eligibility criteria:

Inclusion criteria:

Female patients, ≥18 years, with a hormone-receptor positive, HER2-negative EBC and 0-3 positive LN, T1-3, nuclear grading 1-3, Ki67:10-40%, cM0.

Specific aims:

Primary endpoint is the decision impact of the RS result in patients with mid-range Ki67 on adjuvant chemotherapy in EBC.

Secondary endpoints include the correlation of Ki67 with tumor grade and RS result. Moreover, an economic subanalysis will be done.

Statistical methods:

The change in physicians' treatment recommendations will be measured pre-assay vs. post-assay. The proportion of patients for whom the treatment recommendation changed and the 95% confidence interval will be reported overall and by select groups. McNemar's test will be used to compare the proportion of patients' recommended chemo-hormonal therapy pre-assay vs. post-assay.

Present accrual and target accrual:

Thirteen participating centers recruited 97 patients by the end of April 2017. 600 patients are planned in total.

Contact information for people with a specific interest in the trial:

In case of interest you can contact Ms. Louiza Anastasiadou, Tel: +4969-9533-66395, Fax: +4969-9533-2385, email: louiza.anastasiadou@fdk.info

Citation Format: Anastasiadou L, Aulmann S, Falk S, Baier P, Giesecke D, Buchen S, Hurst U, Krapfl E, Moebus V, Mosch D, Schulmeyer E, Solbach C, Ackermann S, Gabriel B, Jackisch C, Thill M. Oncotype DX®-REMAR(Rhein-Main-Registry)-study: Use of the oncotype DX® assay in early breast cancer in certified breast cancer centers in Rhine-Main Region, Germany [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-06-02.