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

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 stat

Trial Details

NCT ID
NCT07671885
Phase
PHASE3
Sponsor
Tokyo Women's Medical University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Adjuvant systemic therapy based on pathological findings and ET response
  • Adjuvant systemic therapy based on pathological findings
Locations (sample)
  • Akita, Japan|39.71667,140.11667
  • Chiba, Japan|35.6,140.11667
  • Fukuoka, Japan|33.6,130.41667
  • Fukushima, Japan|37.75,140.46667
  • Fukuyama, Japan|34.48333,133.36667

Key Eligibility Criteria

  • Women aged 18 years or older
  • ECOG PS 0-1
  • HR-positive/HER2-negative breast cancer
  • ER expression ≥ 10%

For full eligibility, visit ClinicalTrials.gov.

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