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Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Youg HOPE)
Sponsor: Tokyo Women's Medical University
Summary
Young HOPE/JCOG2402 is a multicenter, randomized phase III study designed to evaluate response-guided therapy following neoadjuvant endocrine therapy to optimize adjuvant treatment in premenopausal HR+/HER2- Breast Cancer. Premenopausal women with intermediate-risk HR-positive/HER2-negative breast cancer derive benefit from the addition of chemotherapy to endocrine therapy. However, previous studies have demonstrated that patients who achieve an endocrine response (Ki-67 ≤10%) following neoadjuvant endocrine therapy have excellent outcomes without chemotherapy, irrespective of menopausal status. These findings suggest that endocrine therapy response may serve as a predictive biomarker to identify premenopausal patients who can safely omit chemotherapy. The primary objective of this study is to evaluate the non-inferiority of an ET response-guided treatment strategy compared with standard surgery followed by adjuvant therapy. The study aims to increase the proportion of patients who can be treated with endocrine therapy alone by omitting chemotherapy in those with highly endocrine-sensitive disease. Eligible patients are randomized 1:1 to upfront surgery or neoadjuvant endocrine therapy with an aromatase inhibitor and ovarian function suppression. The primary endpoint is EFS. Secondary endpoints include overall survival, relapse-free survival, distant recurrrence-free survival, HR-QOL, the rate of endocrine therapy alone in adjuvant therapy, ET response rate in an Arm B, the rate of non-menopause and safety. A total of 950 patients will be enrolled. Randomization is stratified by cN0 vs cN1, HG1 or 2 vs 3, and institution. The JCOG2402 trial addresses an unmet need in adjuvant therapy of premenopausal HR-positive, HER2-negative breast cancer with intermediate risk and may contribute to the establishment of a new treatment strategy.
Official title: A Randomized Phase III Study of Response-Guided Therapy Following Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
950
Start Date
2026-01-28
Completion Date
2039-01-27
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Adjuvant systemic therapy based on pathological findings and ET response
If patients with Oncotype DX RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients) have an ET response (Ki-67 ≤10%), they are treated with endocrine therapy plus OFS without chemotherapy. Patients without an ET response or with high risk (RS ≧26) receive chemotherapy and endocrine therapy with OFS. Patients with RS ≤ 15 (pN0) are treated with tamoxifen. Adjuvant chemotherapy for pN0 and pN1 is TC and anthracycline-taxane, respectively. Aromatase inhibitor or tamoxifen is co-administered with a LHRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of LHRH agonist and dosing schedule is per investigator's discretion. Endocrine treatment beyond 5 years is at the investigator's discretion.
Adjuvant systemic therapy based on pathological findings
Patients with Oncotype DX recurrence score (RS) ≧16 (pN0) or pN1 are treated with chemotherapy and endocrine therapy with ovarian function suppression (OFS). Adjuvant chemotherapy for pN0 and pN1 is TC and anthracycline-taxane, respectively. Aromatase inhibitor or tamoxifen co-administered with a LHRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of LHRH agonist and dosing schedule is per investigator's discretion. Endocrine treatment beyond 5 years is at the investigator's discretion. Patients with RS ≤ 15 are treated with tamoxifen.
Locations (2)
National Cancer Center Hospital East
Kashiwa, Japan
National Cancer Center Hospital
Tokyo, Japan