Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07190443

Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)

Led by Japanese Foundation for Cancer Research · Updated on 2025-09-29

290

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

J

Japanese Foundation for Cancer Research

Lead Sponsor

J

Japan Clinical Oncology Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with first locoregional recurrence (ipsilateral breast tumor, chest wall, or regional lymph node) after primary breast cancer treatment
  • At least one recurrence lesion confirmed by biopsy, surgical specimen, or cytology cell block
  • Lesion pathologically confirmed as invasive breast cancer or diagnosed in cytology cell block if primary cancer was invasive
  • Hormone receptor positive and HER2 negative in all lesions evaluated
  • No prior distant metastasis of breast cancer
  • Imaging confirms no lymph nodes 10 mm or larger and no distant metastasis before registration
  • Age 18 years or older at registration
  • ECOG Performance Status of 0 or 1
  • Chemotherapy for locoregional recurrence allowed before enrollment
  • No bilateral breast cancer
  • No prior treatment with CDK4/6 inhibitors
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Active double cancer requiring treatment
  • Infectious disease needing systemic therapy
  • Fever of 38.0°C or higher at registration
  • Women pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men with partners intending pregnancy
  • Psychiatric illness or symptoms interfering with daily living or trial participation
  • Ongoing systemic steroids equivalent to 10 mg/day prednisolone or other immunosuppressants
  • Unstable angina within past 3 weeks or myocardial infarction within past 6 months
  • Uncontrolled hypertension
  • Uncontrolled diabetes despite insulin or oral therapy
  • Positive for hepatitis B antigen or hepatitis C antibodies (if HCV-RNA undetectable, allowed)
  • Positive for HIV antibodies (testing not mandatory)
  • Interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest CT

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan, 135-8550

Actively Recruiting

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Research Team

Y

Yukinori Ozaki, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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