Abstract OT3-3-01: PROMIS: PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) (2015)

Abstract Background: Gene expression profiling in breast cancer offers the potential to improve prognostic accuracy, treatment choice, and health outcomes in women diagnosed with early-stage breast cancer. Numerous gene-profiling assays are now available, which can be applied to a single tumor specimen to provide physicians with a more complete basis for treatment decisions. • MammaPrint is 70-gene profile to estimate whether patients are at high or low risk of developing metastases within the first 10 years after curative surgery. • BluePrint is an 80-gene molecular subtyping profile that discriminates between three breast cancer subtypes: Luminal, HER2, and Basal. • TargetPrint provides a quantitative measurement of estrogen receptor (ER), progesterone receptor (PR), and HER2. • Oncotype DX measures expression of five reference genes and 16 cancer-related genes, quantifying the risk of distant recurrence in patients with ER+ early breast cancer who are treated with adjuvant hormonal therapy. Trial design: PROMIS is a prospective study that will investigate the additional value of MammaPrint, BluePrint and TargetPrint in women with an intermediate Oncotype DX score. An initial CRF – capturing baseline patient characteristics, pathology information, Oncotype DX score and the recommended treatment plan – will be completed before receiving the MammaPrint result. A second CRF – capturing the actual treatment – will be completed within 4 weeks after receiving the MammaPrint result. Eligibility: The study will include women aged ≥18 years with histologically proven invasive stage I-II, node negative or node positive (N1), hormone receptor positive, HER2 negative breast cancer, who received an Oncotype DX intermediate score (18-30) and who signed informed consent. Objectives: Primary objective: Assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in lymph node negative, hormone receptor positive, HER2 negative breast cancer patients, who received an Oncotype DX intermediate score (18-30) Secondary objectives: • Assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in lymph node positive (N1), hormone receptor positive, HER2 negative breast cancer patients, who received an Oncotype DX intermediate score (18-30) • Assess the distribution of MammaPrint Low and High Risk in patients with an intermediate recurrence score • Assess concordance of TargetPrint ER, PR and HER2 results with Oncotype DX ER, PR and Her2 and with locally assessed IHC/FISH ER, PR and HER2 • Compare clinical subtype based on IHC/FISH ER, PR, HER2 and Ki-67 (if available) with BluePrint molecular subtype Statistical methods: A sample size of 820 lymph node negative, hormone receptor positive, HER2 negative breast cancer patients is required to detect a 20% overall treatment change (5% significance and 90% power). A McNemars test will be performed for the comparison of the two proportions treated (before and after), both expressed as a percentage. Accrual: A total of 385 out of 820 have been enrolled from multiple institutions. Contact information: Clinicaltrials.US@agendia.com Clinical trial registry number: NCT01617954. Citation Format: Hatem Soliman, Sarah Untch, Lisette Stork. PROMIS: PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT3-3-01.