EA1241 - Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol

As breast cancer remains both the most frequently diagnosed cancer and a leading cause of cancer death among women worldwide, improving adjuvant therapies to prevent disease recurrence is a high scientific priority. Furthermore, early-stage breast cancer impacts a large patient population in which treatment decisions frequently hinge on uncertain recurrence risk. Of the approximately 310,720 new cases diagnosed in the United States each year, an estimated 60% are early-stage (American Cancer Society), underscoring the broad application and clinical relevance of individualized risk assessment.

Two successful treatment trials, ECOG-ACRIN Cancer Research Group’s TAILORx (PACCT-1) and SWOG Cancer Research Network’s RxPONDER (S1007), validated the use of the Oncotype DX Breast Recurrence Score® for individualized risk assessments and personalized selection of adjuvant therapy.  Both trials demonstrated that certain patients can safely skip adjuvant chemotherapy, while also defining which patients stand to benefit from chemotherapy. Together, TAILORx and RxPONDER enrolled more than 15,000 patients with breast cancer, with 10,273 in TAILORx and 5,083 in RxPONDER.

Both trials required participants to undergo a biopsy at enrollment to obtain primary tumor tissue specimens for genomic testing, resulting in a large, combined inventory along with corresponding long-term clinical data. The EA1241 study seeks to harness and enhance the value of TAILORx and RxPONDER by retrieving previously collected specimens from patients on these trials who experienced cancer recurrence. These will be paired with their previously submitted primary tissue. Researchers at ECOG-ACRIN will then collaborate with Caris Life Sciences to perform advanced molecular characterization on the paired samples. Their efforts aim to provide insight into factors contributing to disease recurrence, presenting an unparalleled opportunity to generate exceptionally comprehensive data.

As a companion study, the protocol was carefully designed to be convenient for participants and, at the same time, minimize the workload impact for investigators and site staff. The majority of patients will not need to undergo a new biopsy; instead, they simply need to consent to allowing EA1241 researchers to retrieve their recurrent breast cancer tissue previously collected by biopsy. Additionally, data collection is limited, and patients will continue to receive standard of care as determined by their treating physician. Patients will have annual visits for 5 years to collect clinical information, which may be completed via telemedicine or phone. For patients still in active follow-up on TAILORx or RxPONDER, routine visits on those studies may count as the annual EA1241 follow-up.

To be eligible for this study, patients must have been participants in either the TAILORx or RxPONDER trials and meet the criteria for one of three study cohorts:

• Cohort 1: TAILORx participants with any Oncotype DX recurrence score (RS 0-100) who later had a recurrence, at any time after completing their initial treatment. The recurrence may have been in the same area as the original breast cancer (locoregional), in a distant part of the body, or both, and must have been confirmed by a biopsy.
• Cohort 2: RxPONDER participants enrolled on Step 2 (Randomization) with a low to intermediate recurrence score (RS 0-25) who had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence
• Cohort 3: RxPONDER participants enrolled on Step 1 (Screening) but who were not eligible due to a high Oncotype DX recurrence score (RS 26-100). While the RxPONDER trial was for patients with a low-intermediate score (RS 0-25), those with an RS of 26-100 will be eligible for EA1241, whether or not they had a recurrence of breast cancer.

Learn more about EA1241 at ecog-acrin.org.

The study chair for this trial is Joseph A. Sparano, MD (Mount Sinai Tisch Cancer Institute). The study co-chairs are Kevin Kalinsky, MD, MS (Emory University/Winship Cancer Institute) and Rima Patel, MD (Mount Sinai Tisch Cancer Institute).