Status:
RECRUITING
Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
Lead Sponsor:
Japanese Foundation for Cancer Research
Collaborating Sponsors:
Japan Clinical Oncology Group
Conditions:
Breast Cancer
Locoregional Recurrence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 alo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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:
- (i) 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:
- (i) 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).
- (ii) 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.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
February 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 6 2035
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT07190443
Start Date
February 7 2025
End Date
February 6 2035
Last Update
September 29 2025
Active Locations (1)
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1
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550