Response-guided therapy after neoadjuvant endocrine therapy to tailor adjuvant treatment in premenopausal HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized phase 3 trial comparing a response-guided adjuvant strategy after neoadjuvant endocrine therapy to the standard approach of surgery followed by adjuvant treatment. It includes premenopausal women with intermediate-risk, HR-positive/HER2-negative breast cancer and explores non-inferiority of omitting chemotherapy in those whose tumors show a strong endocrine response (Ki-67 ≤10%). The study uses pathological findings and early treatment response to decide subsequent systemic therapy. Primary goal is to see if avoiding chemotherapy in responders remains non-inferior in outcomes. Secondary aims include safety and overall treatment impact.

Why it matters

Who can join: the full rules

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.

Where it's running

• Akita University Hospita
  Akita, Japan Recruiting
• Chiba Cancer Center
  Chiba, Japan Recruiting
• National Hospital Organization Kyushu Cancer Center
  Fukuoka, Japan Recruiting
• Fukushima Medical University Hospital
  Fukushima, Japan Recruiting
• National Hospital Organization Fukuyama Medical Center
  Fukuyama, Japan Recruiting
• Kansai Medical University Hospital
  Hirakata, Japan Recruiting

Study contacts

• Study coordinator: Makiko Ono, MD
• Email: makikono@gmail.com
• Phone: +81333538111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.