NCT07671885 Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE)
| NCT ID | NCT07671885 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tokyo Women's Medical University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 950 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2038-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 950 participants in total. It began in 2026-01-28 with a primary completion date of 2038-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18 years or older 2. ECOG PS 0-1 3. HR-positive/HER2-negative breast cancer 4. ER expression ≥ 10% 5. cN0; HG 1: 3 cm\<T≤5 cm, HG 2: 2 cm\<T≤5 cm or HG3: 1 cm\<T≤5 cm cN1; cT\<5 cm and HG 1/HG 2 6. Premenopausal women with spontaneous menses within 12 months 7. No distant metastasis of breast cancer 8. No prior diagnosis of breast cancer. 9. No multiple regions of breast cancer 10. No contralateral breat cancer 11. Adequate organ function Exclusion Criteria: 1. Presence of active double cancer (synchronous malignancy requiring treatment). 2. Ongoing infectious disease requiring systemic therapy. Fever ≥38.0°C at the time of registration. 3. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant. 4. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation. 5. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents. 6. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months. 7. Uncontrolled hypertension. 8. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy. 9. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.) 10. Positive for HIV antibodies (HIV testing is not mandatory.) 11. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07671885 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07671885 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 950 participants.
Is NCT07671885 currently recruiting?
Yes, NCT07671885 is actively recruiting participants. Contact the research team at makikono@gmail.com for enrollment information.
Where is the NCT07671885 trial being conducted?
This trial is being conducted at Akita, Japan, Chiba, Japan, Fukuoka, Japan, Fukushima, Japan and 11 additional locations.
Who is sponsoring the NCT07671885 clinical trial?
NCT07671885 is sponsored by Tokyo Women's Medical University. The trial plans to enroll 950 participants.
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