RxPONDER — A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

Phase 3 · 2021 · Breast Cancer

Design

Randomized patients with 1-3 positive nodes and Oncotype DX Recurrence Score of 0-25 to endocrine therapy alone versus chemotherapy followed by endocrine therapy.

Population

HR-positive, HER2-negative breast cancer with 1-3 positive axillary lymph nodes and a 21-gene Recurrence Score of 0-25.

Primary Endpoint

invasive disease-free survival (IDFS)

Key Result

No chemotherapy benefit in postmenopausal women (5-yr IDFS 91.9% vs 91.3%), but a significant benefit in premenopausal women (5-yr IDFS 94.2% with chemo vs 89.0%; HR 0.60).

Guideline Impact

NCCN incorporates the 21-gene Recurrence Score to guide chemotherapy in node-positive, postmenopausal HR+/HER2- breast cancer