New Data Compare Genomic Profiling Results for Premenopausal Women with Early-Stage Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Agendia

From: PR Newswire

PROMIS study findings presented today at SABCS 2019

Agendia, Inc., a world leader in precision oncology for breast cancer, announced today new data comparing genomic profiling results for patients under the age of 50 with early-stage breast cancer. The data, which are being presented for the first time today at the 2019 San Antonio Breast Cancer Symposium (SABCS), show that the MammaPrint 70-gene assay may more effectively identify premenopausal women who may safely avoid chemotherapy.

One of the biggest challenges physicians face when treating patients with early stage, curable breast cancer is choosing a treatment path that will mitigate the risk of disease recurrence, while avoiding over- or undertreatment. Genomic profiling has helped address this clinical need, but recent findings suggest age may impact the veracity of results for some assays. A follow up to the TAILORx study published in 2018 led to a change in recurrence score (RS) stratification for patients under 50 and, more importantly, left the ideal treatment plan for those with a RS of 21-25 unclear.

“Understanding how patient age may affect possible benefit from chemotherapy is a critically important question that has needed further exploration and clarification,” said William Audeh, MD, MS, chief medical officer, Agendia.

The Agendia Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score (PROMIS) trial previously demonstrated that MammaPrint, which provides a binary, High Risk or Low Risk of recurrence, delivers clinically actionable results for patients who receive a RS of 18-30 by the 21-gene assay. The findings presented today at SABCS represent a sub-analysis of the PROMIS data, which Agendia conducted to help determine the potential of the MammaPrint test to clarify adjuvant chemotherapy decisions for premenopausal women.

Results – which are statistically significant – demonstrate that 58 percent of women age 50 and under with RS 18-20 and 46 percent of those with RS 21-25 are categorized as MammaPrint Low, indicating that they may safely forgo chemotherapy. Additionally, 15 percent of women with RS 26-30 were found to be MammaPrint Low Risk and may be potential candidates for de-escalation of adjuvant chemotherapy.

“Treatment recommendations in ER+ patients <50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study” can be found at:

About Agendia
Agendia is a molecular diagnostics company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially-available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth.  Together, MammaPrint® and BluePrint® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia’s assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit