Adjuvant abemaciclib plus hormone therapy after locoregional recurrence of HR-positive, HER2-negative breast cancer

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.

This will test whether adding abemaciclib to standard hormone therapy helps people with HR-positive, HER2-negative breast cancer who have had their first locoregional recurrence.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Japanese Foundation for Cancer Research (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Koto-ku, Tokyo)
• Trial ID: NCT07190443 on ClinicalTrials.gov

What this trial studies

The JCOG2313 phase III randomized trial enrolls patients with hormone receptor–positive, HER2‑negative breast cancer who have undergone curative treatment for their first locoregional recurrence. Participants are randomly assigned to receive adjuvant abemaciclib combined with standard endocrine therapy or to receive endocrine therapy alone. The study follows patients for disease outcomes and safety to see if adding abemaciclib reduces the risk of further recurrence or distant metastasis. Endocrine therapy options in the trial include letrozole, anastrozole, exemestane, or tamoxifen.

Who should consider this trial

Good fit: People with a first locoregional recurrence of invasive HR-positive, HER2-negative breast cancer confirmed by pathology, no prior distant metastasis, and who have completed curative treatment are eligible.

Not a fit: Patients whose recurrent tumor is HR-negative or HER2-positive, who have confirmed distant metastasis, or who have had multiple prior recurrences are unlikely to benefit from this specific treatment approach.

Why it matters

Potential benefit: If successful, adding abemaciclib could lower the risk of distant metastasis and recurrence after locoregional relapse, improving long-term outcomes.

How similar studies have performed: CDK4/6 inhibitors such as abemaciclib have shown benefit as adjuvant therapy in high-risk early breast cancer, but their use specifically after locoregional recurrence is largely untested.

Eligibility criteria

Inclusion criteria:

1. 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
2. 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.
3. No prior diagnosis of distant metastasis of breast cancer.
4. Imaging assessment before registration confirms:

   No lymph nodes ≥10 mm in short axis No evidence of distant metastasis
5. Age ≥18 years at the time of registration.
6. ECOG Performance Status of 0 or 1.
7. Chemotherapy for LRR is allowed prior to enrollment.
8. The patient does not have bilateral breast cancer.
9. No prior history of treatment with CDK4/6 inhibitors.
10. Written informed consent has been obtained for participation in this clinical trial.

Exclusion Criteria:

1. Presence of active double cancer (synchronous malignancy requiring treatment).
2. Ongoing infectious disease requiring systemic therapy.
3. Fever ≥38.0°C at the time of registration.
4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.
5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.
6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents.
7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.
8. Uncontrolled hypertension.
9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.
10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)
11. Positive for HIV antibodies (HIV testing is not mandatory.)
12. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.

Where this trial is running

Koto-ku, Tokyo

• Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Yukinori Ozaki, MD. PhD.

Conditions Breast Cancer; Locoregional Recurrence; Abemaciclib; Endocrine Therapy