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New treatment option for Breast Cancer
Official title Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
ClinicalTrials.gov ID: NCT07190443
What this study is testing
What is Endocrine therapy + Abemaciclib?
Endocrine therapy + Abemaciclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR...
- 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)...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Koto-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Koto-ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.