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NCT Number: NCT07671885

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 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Akita University Hospita, Akita, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 years or older
  • ECOG PS 0-1
  • HR-positive/HER2-negative breast cancer
  • ER expression ≥ 10%
  • 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
  • Premenopausal women with spontaneous menses within 12 months
  • No distant metastasis of breast cancer
  • No prior diagnosis of breast cancer.
  • No multiple regions of breast cancer
  • No contralateral breat cancer
  • Adequate organ function

Exclusion criteria

  • Presence of active double cancer (synchronous malignancy requiring treatment).
  • Ongoing infectious disease requiring systemic therapy. Fever ≥38.0°C at the time of registration.
  • Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.
  • Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.
  • Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents.
  • Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.
  • Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)
  • Positive for HIV antibodies (HIV testing is not mandatory.)
  • Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.

Treatment and study plan

Adjuvant systemic therapy based on pathological findings and ET response

Drug

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

Drug

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.

Primary outcomes

  1. Event free survival

    Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)

    Time from randomization to the first diagnosis of local invasive recurrence, regional recurrence, distant recurrence, contralateral invasive breast cancer, inoperable progressive disease during neoadjuvant endocrine therapy, second primary invasive non-breast cancer (excluding non-melanoma skin cancer and in situ cervical cancer), or death from any cause

Secondary outcomes

  1. Overall survival

    Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)

    Time from randomization to death from any cause

  2. Relapse-free survival

    Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)

    Time from randomization to the first diagnosis of relapse or death from any cause

  3. Distant recurrence-free survival

    Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)

    Time from randomization to the first diagnosis of distant recurrence of breast cancer or death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Makiko Ono, MD

CONTACT

[email protected]

+81333538111

Sponsors and collaborators

Lead sponsor

Tokyo Women's Medical University

Other

Collaborators

  • Japan Clinical Oncology Group

Registry information

Official study 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)

Acronym: YoungHOPE

Important dates

Study start
2026
Primary completion
2038
Study completion
2039
First posted
Jun 26, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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