Abstract OT1-2-02: PROMIS: Prospective study of MammaPrint in breast cancer patients with an intermediate recurrence score (PROMIS)
Authors: Soliman HH , Untch S , Stork-Sloots L 
Published: August 2014

Background: Gene expression profiling 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 a 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, and predicting clinical benefit with adjuvant chemotherapy

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: 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

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

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 150 out of 820 have been enrolled from multiple institutions in the US.

Clinical trial registry number: NCT01617954.

Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT1-2-02.