MammaPrint (MP) and BluePrint (BP) signatures have been validated in the adjuvant setting to identify patients for which adjuvant chemotherapy (CT) could be spare. Neoadjuvant Chemotherapy (NCT) is a common approach for patients (pts) with clinically high-risk Early Breast Cancer (EBC). Other options include neoadjuvant endocrine therapy (NET) or primary surgery particularly for those patients with low-risk luminal tumors. In the DETERMIND study, we explore whether pre-operative use of MP/BP may help clinicians to reinforce the best treatment strategy for clinically high-risk patients.
DETERMIND is a prospective, open-label, multicenter study, assessing the utility of the MP/BP signature on the decision-making process of optimal therapy for patients with operable clinically high-risk HR+/HER2- EBC, stage II-IIIA (up to N1) and recommendation for NCT. A total of 165 pts have been included in 11 centers. Patient data will be collected at inclusion (baseline), and at the time of MP/BP results and at 1- and 3-years follow-up.
This initial analysis includes the first 99 pts: Median age was 57 years (range 31-85), 94% were stage II, and 51% cN1. By MP/BP, 37 pts (37%) were classified as Luminal A, 58 (59%) as Luminal-B, and 4 cases presented as non-Luminal phenotype (3 Basal, 1 HER2). In line with MP/BP results, 44 pts did not receive NCT. In the MP/BP Luminal A group, 35 pts (95%) did not receive NCT, and for 19 pts it was replaced by NET. Patients with MP High-Risk received NCT in 53 cases (85%). The confidence on the final treatment decision by physicians and patients was significantly increased by the MP/BP result.
In clinical high-risk HR+/HER2- EBC pts with criteria for NCT there is a high prevalence (35%) of MP/BP Luminal A, who were able to de-escalate NCT. MP/BP also further supported decision to administered NCT in the majority (85%) of patients with MP High Risk. Our findings support the utility of MP/BP in high clinical risk HR+/HER2- EBC to guide neoadjuvant therapy decision and provide further information and confidence to clinicians and patients for shared-decision making.
FISABIO.
Agendia N.V.
A. Llombart Cussac: Financial Interests, Institutional, Project Lead: Agendia; Financial Interests, Personal, Expert Testimony: Agendia; Financial Interests, Personal, Invited Speaker: Agendia. All other authors have declared no conflicts of interest.