Breast CancerPhase 3AURANCT07190443
Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
A Phase 3 study testing Endocrine therapy + Abemaciclib and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen in people with Breast Cancer and Locoregional Recurrence, run by Japanese Foundation for Cancer Research at 1 site in Japan.
Trial summary
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Locoregional Recurrence, Abemaciclib
- What is being tested?
- Endocrine therapy + Abemaciclib and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteJapan
- Study dates
- 7 Feb 2025to 6 Feb 2035
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following:
- Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence
- At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following:
- Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive).
- Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative.
- ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.
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- No prior diagnosis of distant metastasis of breast cancer.
- Imaging assessment before registration confirms:
- No lymph nodes ≥10 mm in short axis No evidence of distant metastasis
- Age ≥18 years at the time of registration.
- ECOG Performance Status of 0 or 1.
- Chemotherapy for LRR is allowed prior to enrollment.
- The patient does not have bilateral breast cancer.
- No prior history of treatment with CDK4/6 inhibitors.
- Written informed consent has been obtained for participation in this clinical trial.
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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Yukinori Ozaki, MD. PhD., +81335200111, yukinori.ozaki@jfcr.or.jp
About this study
Official title: Randomized Phase III Trial for Evaluating the Efficacy of Adjuvant Abemaciclib in Patients With Locoregional Recurrence of Hormone Receptor-positive, HER2-negative Breast Cancer. JCOG2313, AURA Trial.
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR).
Although HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely.
Read more
Abemaciclib, a CDK4/6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR.
Eligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution.
Additionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response.
The JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.
- Conditions
- Breast Cancer, Locoregional Recurrence, Abemaciclib, Endocrine Therapy
- Being tested
- Endocrine therapy + Abemaciclib, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine therapy + AbemaciclibDrug
This intervention consists of adjuvant endocrine therapy in combination with abemaciclib, a CDK4/6 inhibitor, administered to patients with HR-positive, HER2-negative breast cancer who have undergone curative-intent local treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence.
Abemaciclib is given orally at a dose of 150 mg twice daily for a maximum of 2 years, in accordance with the approved dosing regimen in the adjuvant setting. The choice of endocrine therapy-aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression-is determined based on menopausal status and prior treatment history.
Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenDrug
This intervention consists of adjuvant endocrine therapy alone in patients with HR-positive, HER2-negative breast cancer who have undergone curative treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence.
The choice of endocrine therapy (aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression) is determined based on the patient's menopausal status and prior treatment history, as specified in the protocol. Treatment is continued for five years or until disease recurrence, unacceptable toxicity, or withdrawal of consent.
This intervention does not include CDK4/6 inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Standard endocrine therapy (Arm A) | Active comparator | Participants in Arm A will receive standard endocrine therapy alone as adjuvant treatment following curative-intent local therapy for first locoregional recurrence (LRR) of hormone receptor (HR)-positive, HER2-negative breast cancer. No CDK4/6 inhibitor is administered in this arm. Receives: Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen |
| Endocrine therapy in combination with abemaciclib (Arm B) | Experimental | Participants in Arm B will receive endocrine therapy in combination with abemaciclib following curative-intent local treatment for first LRR of HR-positive, HER2-negative breast cancer. Receives: Drug: Endocrine therapy + Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival
Defined as the time from randomization to the first occurrence of one of the following events:
- Recurrence of invasive breast cancer in the ipsilateral breast, chest wall, or regional lymph nodes (locoregional recurrence);
- Distant recurrence of breast cancer (metastatic disease);
- Invasive contralateral breast cancer;
- Second primary invasive non-breast cancer (excluding non-melanoma skin cancer and in situ cervical cancer);
- Death from any cause. Patients who have not experienced any of the above events will be censored at the date of last disease assessment.
Measured: Up to 9 years (4 years of accrual and 5 years of follow-up)
Secondary outcomes (3)
Distant recurrence-free survival
Distant Recurrence-Free Survival (DRFS) is defined as the time from randomization to the first occurrence of distant recurrence of breast cancer or death from any cause, whichever occurs first.
Distant recurrence is defined as radiographically or pathologically confirmed metastatic disease outside of the locoregional area.
Patients without events will be censored at the date of last disease assessment.
DRFS is evaluated as a secondary endpoint to assess the effectiveness of treatment in preventing distant metastatic progression.
Measured: Up to 9 years (4 years of accrual and 5 years of follow-up)
Breast cancer-specific survival
Breast Cancer-Specific Survival (BCSS) is defined as the time from randomization to death due to breast cancer.
Deaths from other causes (non-breast cancer-related) will be considered competing events and will be censored at the time of death.
Patients who are alive at the time of analysis or lost to follow-up will be censored at the date of last known contact.
BCSS is included as a secondary endpoint to evaluate the disease-specific mortality benefit of the intervention.
Measured: Up to 9 years (4 years of accrual and 5 years of follow-up)
Overall survival
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Patients who are alive at the time of analysis or lost to follow-up will be censored at the date of last known contact.
OS will be assessed as a secondary endpoint to evaluate the overall survival benefit of adjuvant abemaciclib in combination with endocrine therapy in the post-recurrence setting.
Measured: Up to 9 years (4 years of accrual and 5 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 posted24 Sep 2025
- Study start7 Feb 2025
- Primary completion6 Feb 2034 (estimated)
- Study completion6 Feb 2035 (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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japanese Foundation for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Responsible party
- Principal investigator, Yukinori Ozaki, Japanese Foundation for Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190443
- Sponsor's protocol ID
- JCOG2313
- Other IDs
- jRCTs031240666
- Acronym
- AURA
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plans for sharing IPD have not been finalized. Data sharing may be considered in the future pending appropriate ethical and regulatory approvals.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial for Evaluating the Efficacy of Adjuvant Abemaciclib in Patients With Locoregional Recurrence of Hormone Receptor-positive, HER2-negative Breast Cancer. JCOG2313, AURA Trial.
- ClinicalTrials.gov ID
- NCT07190443
- Acronym / sponsor ID
- AURA / JCOG2313
- Conditions
- Breast Cancer, Locoregional Recurrence, Abemaciclib, Endocrine Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Japanese Foundation for Cancer ResearchUniversity, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 6 Feb 2034 (estimated)
- Study completion
- 6 Feb 2035 (estimated)
- First posted
- 24 Sep 2025 (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.
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR).
Although HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely.
Abemaciclib, a CDK4/6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR.
Eligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution.
Additionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response.
The JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard endocrine therapy (Arm A) | Active comparator | Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenParticipants in Arm A will receive standard endocrine therapy alone as adjuvant treatment following curative-intent local therapy for first locoregional recurrence (LRR) of hormone receptor (HR)-positive, HER2-negative breast cancer. No CDK4/6 inhibitor is administered in this arm. |
| Endocrine therapy in combination with abemaciclib (Arm B) | Experimental | Drug: Endocrine therapy + AbemaciclibParticipants in Arm B will receive endocrine therapy in combination with abemaciclib following curative-intent local treatment for first LRR of HR-positive, HER2-negative breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following:
- At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following:
- ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.
- No prior diagnosis of distant metastasis of breast cancer.
- Imaging assessment before registration confirms:
Key exclusion criteria (12 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.
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 |
|---|---|---|
| Endocrine therapy + AbemaciclibThis intervention consists of adjuvant endocrine therapy in combination with abemaciclib, a CDK4/6 inhibitor, administered to patients with HR-positive, HER2-negative breast cancer who have undergone curative-intent local treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. Abemaciclib is given orally at a dose of 150 mg twice daily for a maximum of 2 years, in accordance with the approved dosing regimen in the adjuvant setting. The choice of endocrine therapy-aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression-is determined based on menopausal status and prior treatment history. | Drug | Endocrine therapy in combination with abemaciclib (Arm B) |
| Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenThis intervention consists of adjuvant endocrine therapy alone in patients with HR-positive, HER2-negative breast cancer who have undergone curative treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. The choice of endocrine therapy (aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression) is determined based on the patient's menopausal status and prior treatment history, as specified in the protocol. Treatment is continued for five years or until disease recurrence, unacceptable toxicity, or withdrawal of consent. This intervention does not include CDK4/6 inhibitors. | Drug | Standard endocrine therapy (Arm A) |
Primary outcome
Invasive disease-free survival
Time frame: Up to 9 years (4 years of accrual and 5 years of follow-up)
Defined as the time from randomization to the first occurrence of one of the following events: * Recurrence of invasive breast cancer in the ipsilateral breast, chest wall, or regional lymph nodes (locoregional recurrence); * Distant recurrence of breast cancer (metastatic disease); * Invasive contralateral breast cancer; * Second primary invasive non-breast cancer (excluding non-melanoma skin cancer and in situ cervical cancer); * Death from any cause. Patients who have not experienced any of the above events will be censored at the date of last disease assessment.
3 secondary outcomes
Distant recurrence-free survival
Time frame: Up to 9 years (4 years of accrual and 5 years of follow-up)
Breast cancer-specific survival
Time frame: Up to 9 years (4 years of accrual and 5 years of follow-up)
Overall survival
Time frame: Up to 9 years (4 years of accrual and 5 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 29 Sep 2025.
- Individual participant dataSharing planned: Undecided. Plans for sharing IPD have not been finalized. Data sharing may be considered in the future pending appropriate ethical and regulatory approvals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endocrine therapy + Abemaciclib and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen in people with Breast Cancer and Locoregional Recurrence, run by Japanese Foundation for Cancer Research at 1 site 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 15 inclusion and 12 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yukinori Ozaki, MD. PhD. (+81335200111, yukinori.ozaki@jfcr.or.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (time frame: Up to 9 years (4 years of accrual and 5 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 29 Sep 2025.