Breast CancerPhase 3YoungHOPENCT07671885
Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE)
A Phase 3 study testing Adjuvant systemic therapy based on pathological findings and ET response and Adjuvant systemic therapy based on pathological findings in people with Breast Cancer, run by Tokyo Women's Medical University at 49 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant systemic therapy based on pathological findings and ET response and Adjuvant systemic therapy based on pathological findings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 49 sitesJapan
- Study dates
- 28 Jan 2026to 27 Jan 2039
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
49 sites in 1 country. Contact the study team or a site near you to ask about taking part.
49 sites in 1 country
Japan49 sites, 49 recruiting
- Recruiting
Akita University Hospita
Akita
- Recruiting
Chiba Cancer Center
Chiba
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka
- Recruiting
Fukushima Medical University Hospital
Fukushima
- Recruiting
National Hospital Organization Fukuyama Medical Center
Fukuyama
- Not yet recruiting
Hamamatsu University School of Medicine
Hamamatsu
- Recruiting
Kansai Medical University Hospital
Hirakata
- Recruiting
Hiroshima City North Medical Center Asa Citizens Hospital
Hiroshima
- Recruiting
Hiroshima University Hospital
Hiroshima
- Recruiting
Ibaraki Prefectural Central Hospital
Ibaraki
- Recruiting
Tokai University Hospital
Isehara
- Recruiting
Social medical corporation Hakuaikai Sagara Hospital
Kagoshima
- Recruiting
National Cancer Center Hospital East
Kashiwa
- Recruiting
Saitama Medical Center
Kawagoe
- Recruiting
Kitakyushu Municipal Medical Center
Kitakyushu
- Recruiting
National Hospital Organization Kure Medical Center
Kure
- Recruiting
Gunma University Hospital
Maebashi
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama
- Recruiting
Aichi Cancer Center
Nagoya
- Recruiting
Nagoya City University
Nagoya
- Recruiting
Nagoya University Hospital
Nagoya
- Recruiting
NHO Nagoya Medical Center
Nagoya
- Recruiting
Niigata Cancer Center Hospital
Niigata
- Recruiting
National Hospital Organization Nagasaki Medical Center
Ōmura
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka
- Not yet recruiting
Osaka International Cancer Institute
Osaka
- Recruiting
Gunma Prefectural Cancer Center
Ōta-ku
- Recruiting
Kitasato University Hospital
Sagamihara
- Recruiting
Saitama Cancer Center
Saitama
- Recruiting
Kindai University Hospital
Sakai
- Recruiting
Hokkaido Cancer Center
Sapporo
- Recruiting
Tohoku University Hospital
Sendai
- Recruiting
Shizuoka Cancer Center
Shizuoka
- Recruiting
Shizuoka General Hospital
Shizuoka
- Recruiting
Institute of Science Tokyo Hospital
Tokyo
- Recruiting
National Cancer Center Hospital
Tokyo
- Recruiting
National Center for Global Health and Medicine
Tokyo
- Recruiting
National Hospital Organization Tokyo Medical Center
Tokyo
- Recruiting
Showa Medical University Hospital
Tokyo
- Recruiting
St.Luke's International Hospital
Tokyo
- Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo
- Recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo
- Not yet recruiting
Tokyo Women's Medical University Hospital
Tokyo
- Recruiting
Toranomon Hospital
Tokyo
- Recruiting
Mie University Hospital
Tsu
- Recruiting
Tsukuba University Hospital
Tsukuba
- Recruiting
Yamaguchi University Hospital
Ube
- Recruiting
Yao Municipal Hospital
Yao
- Recruiting
Kanagawa Cancer Center
Yokohama
About this study
Official 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)
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant systemic therapy based on pathological findings and ET response, Adjuvant systemic therapy based on pathological findings
- Keywords
- Premenopausal women, HR+HER2-, neoadjuvant endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant systemic therapy based on pathological findings and ET responseDrug
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 findingsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Upfront surgery (Arm A) | Active comparator | Participants in Arm A will undergo breast surgery and adjuvant systemic treatment. Receives: Drug: Adjuvant systemic therapy based on pathological findings |
| Neoadjuvant endocrine therapy (Arm B) | Experimental | Participants in Arm B will receive neoadjuvant endocrine therapy of aromatase inhibitor and OFS for three months, followed by breast surgery. Receives: Drug: Adjuvant systemic therapy based on pathological findings and ET response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
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
Measured: Up to 12 years (5 years of accrual and 7 years of follow-up)
Secondary outcomes (3)
Overall survival
Time from randomization to death from any cause
Measured: Up to 12 years (5 years of accrual and 7 years of follow-up)
Relapse-free survival
Time from randomization to the first diagnosis of relapse or death from any cause
Measured: Up to 12 years (5 years of accrual and 7 years of follow-up)
Distant recurrence-free survival
Time from randomization to the first diagnosis of distant recurrence of breast cancer or death from any cause
Measured: Up to 12 years (5 years of accrual and 7 years of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start28 Jan 2026
- Primary completion27 Jan 2038 (estimated)
- Study completion27 Jan 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Women's Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Responsible party
- Principal investigator, Makiko Ono, Tokyo Women's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671885
- Sponsor's protocol ID
- JCOG2402
- Other IDs
- jRCTs031250687
- Acronym
- YoungHOPE
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07671885
- Acronym / sponsor ID
- YoungHOPE / JCOG2402
- Conditions
- Breast Cancer
- Keywords
- Premenopausal women, HR+HER2-, neoadjuvant endocrine therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Tokyo Women's Medical UniversityUniversity, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 27 Jan 2038 (estimated)
- Study completion
- 27 Jan 2039 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront surgery (Arm A) | Active comparator | Drug: Adjuvant systemic therapy based on pathological findingsParticipants in Arm A will undergo breast surgery and adjuvant systemic treatment. |
| Neoadjuvant endocrine therapy (Arm B) | Experimental | Drug: Adjuvant systemic therapy based on pathological findings and ET responseParticipants in Arm B will receive neoadjuvant endocrine therapy of aromatase inhibitor and OFS for three months, followed by breast surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant systemic therapy based on pathological findings and ET responseIf 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. | Drug | Neoadjuvant endocrine therapy (Arm B) |
| Adjuvant systemic therapy based on pathological findingsPatients 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. | Drug | Upfront surgery (Arm A) |
Primary outcome
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
3 secondary outcomes
Overall survival
Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)
Relapse-free survival
Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)
Distant recurrence-free survival
Time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant systemic therapy based on pathological findings and ET response and Adjuvant systemic therapy based on pathological findings in people with Breast Cancer, run by Tokyo Women's Medical University at 49 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Makiko Ono, MD (+81333538111, makikono@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: Up to 12 years (5 years of accrual and 7 years of follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.