Response-Guided Therapy Versus Standard Surgery and Adjuvant Treatment in Premenopausal Women with HR-PositiveHER2-Negative Breast Cancer A Phase III Randomized Trial

What this Trial Is About

This research investigates response-guided therapy after neoadjuvant endocrine treatment to improve adjuvant care in premenopausal women with hormone receptor-positive, HER2-negative breast cancer. It focuses on optimizing treatment by identifying patients who may safely avoid chemotherapy based on their response to endocrine therapy. The study is a multicenter, randomized phase III trial aiming to compare this approach to standard surgery followed by adjuvant therapy. Participants are randomly assigned to one of two groups one group undergoes upfront breast surgery followed by adjuvant systemic therapy based on pathological findings, and the other group receives neoadjuvant endocrine therapy with an aromatase inhibitor and ovarian function suppression for three months before surgery. Adjuvant treatments vary depending on the patients Oncotype DX recurrence score and endocrine therapy response, with options including endocrine therapy alone, chemotherapy combined with endocrine therapy, or tamoxifen. During the study, participants are monitored for outcomes such as event-free survival, overall survival, relapse-free survival, and distant recurrence-free survival over up to 12 years. Researchers also assess quality of life, safety, and the rate of endocrine therapy use without chemotherapy. The study involves long-term follow-up to evaluate the effectiveness of response-guided therapy in improving treatment decisions for premenopausal women with this breast cancer subtype.

Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE)