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

4. juli 2026 opdateret af: Makiko Ono, Tokyo Women's Medical University

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)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

950

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Japan
      • Akita, Japan
        • Rekruttering
        • Akita University Hospita
      • Chiba, Japan
        • Rekruttering
        • Chiba Cancer Center
      • Fukuoka, Japan
        • Rekruttering
        • National Hospital Organization Kyushu Cancer Center
      • Fukushima, Japan
        • Rekruttering
        • Fukushima Medical University Hospital
      • Fukuyama, Japan
        • Rekruttering
        • National Hospital Organization Fukuyama Medical Center
      • Hamamatsu, Japan
        • Ikke rekrutterer endnu
        • Hamamatsu University School of Medicine
      • Hirakata, Japan
        • Rekruttering
        • Kansai Medical University Hospital
      • Hiroshima, Japan
        • Rekruttering
        • Hiroshima University Hospital
      • Hiroshima, Japan
        • Rekruttering
        • Hiroshima City North Medical Center Asa Citizens Hospital
      • Ibaraki, Japan
        • Rekruttering
        • Ibaraki Prefectural Central Hospital
      • Isehara, Japan
        • Rekruttering
        • Tokai University Hospital
      • Kagoshima, Japan
        • Rekruttering
        • Social medical corporation Hakuaikai Sagara Hospital
      • Kashiwa, Japan
        • Rekruttering
        • National Cancer Center Hospital East
      • Kawagoe, Japan
        • Rekruttering
        • Saitama Medical Center
      • Kitakyushu, Japan
        • Rekruttering
        • Kitakyushu Municipal Medical Center
      • Kure, Japan
        • Rekruttering
        • National Hospital Organization Kure Medical Center
      • Maebashi, Japan
        • Rekruttering
        • Gunma University Hospital
      • Matsuyama, Japan
        • Rekruttering
        • National Hospital Organization Shikoku Cancer Center
      • Nagoya, Japan
        • Rekruttering
        • Nagoya University Hospital
      • Nagoya, Japan
        • Rekruttering
        • NHO Nagoya Medical Center
      • Nagoya, Japan
        • Rekruttering
        • Aichi Cancer Center
      • Nagoya, Japan
        • Rekruttering
        • Nagoya City University
      • Niigata, Japan
        • Rekruttering
        • Niigata Cancer Center Hospital
      • Osaka, Japan
        • Ikke rekrutterer endnu
        • Osaka International Cancer Institute
      • Osaka, Japan
        • Rekruttering
        • National Hospital Organization Osaka National Hospital
      • Sagamihara, Japan
        • Rekruttering
        • Kitasato University Hospital
      • Saitama, Japan
        • Rekruttering
        • Saitama Cancer Center
      • Sakai, Japan
        • Rekruttering
        • Kindai University Hospital
      • Sapporo, Japan
        • Rekruttering
        • Hokkaido Cancer Center
      • Sendai, Japan
        • Rekruttering
        • Tohoku University Hospital
      • Shizuoka, Japan
        • Rekruttering
        • Shizuoka Cancer Center
      • Shizuoka, Japan
        • Rekruttering
        • Shizuoka General Hospital
      • Tokyo, Japan
        • Rekruttering
        • National Cancer Center Hospital
      • Tokyo, Japan
        • Rekruttering
        • Toranomon Hospital
      • Tokyo, Japan
        • Rekruttering
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Tokyo, Japan
        • Ikke rekrutterer endnu
        • Tokyo Women's Medical University Hospital
      • Tokyo, Japan
        • Rekruttering
        • National Center for Global Health and Medicine
      • Tokyo, Japan
        • Rekruttering
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Tokyo, Japan
        • Rekruttering
        • Institute of Science Tokyo Hospital
      • Tokyo, Japan
        • Rekruttering
        • National Hospital Organization Tokyo Medical Center
      • Tokyo, Japan
        • Rekruttering
        • Showa Medical University Hospital
      • Tokyo, Japan
        • Rekruttering
        • St.Luke's International Hospital
      • Tsu, Japan
        • Rekruttering
        • Mie University Hospital
      • Tsukuba, Japan
        • Rekruttering
        • Tsukuba University Hospital
      • Ube, Japan
        • Rekruttering
        • Yamaguchi University Hospital
      • Yao, Japan
        • Rekruttering
        • Yao Municipal Hospital
      • Yokohama, Japan
        • Rekruttering
        • Kanagawa Cancer Center
      • Ōmura, Japan
        • Rekruttering
        • National Hospital Organization Nagasaki Medical Center
      • Ōta-ku, Japan
        • Rekruttering
        • Gunma Prefectural Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Upfront surgery (Arm A)
Participants in Arm A will undergo breast surgery and adjuvant systemic treatment.
Medicin: 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.
Eksperimentel: Neoadjuvant endocrine therapy (Arm B)
Participants in Arm B will receive neoadjuvant endocrine therapy of aromatase inhibitor and OFS for three months, followed by breast surgery.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event free survival
Tidsramme: 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
Up to 12 years (5 years of accrual and 7 years of follow-up)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival
Tidsramme: Up to 12 years (5 years of accrual and 7 years of follow-up)
Time from randomization to death from any cause
Up to 12 years (5 years of accrual and 7 years of follow-up)
Relapse-free survival
Tidsramme: 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
Up to 12 years (5 years of accrual and 7 years of follow-up)
Distant recurrence-free survival
Tidsramme: 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
Up to 12 years (5 years of accrual and 7 years of follow-up)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tokyo Women's Medical University

Samarbejdspartnere

Japan Clinical Oncology Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. januar 2026

Primær færdiggørelse (Anslået)

27. januar 2038

Studieafslutning (Anslået)

27. januar 2039

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JCOG2402
  • jRCTs031250687 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for individuelle deltagerdata (IPD)

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