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JCOG2313: Randomized phase III trial for evaluating the efficacy of adjuvant abemaciclib in patients with locoregional recurrence of hormone receptor-positive, HER2-negative breast cancer (AURA)

JCOG2313: Randomized phase III trial for evaluating the efficacy of adjuvant abemaciclib in patients with locoregional recurrence of hormone receptor-positive, HER2-negative breast cancer (AURA)

HARA Fumikata

Aichi Cancer Center

1-1, kanokoden, chikusa-ku, Nagoya, 464-8681, Japan

f.hara@aichi-cc.jp

KATAOKA Ayumi

Aichi Cancer Center

1-1, kanokoden, chikusa-ku, Nagoya, 464-8681, Japan

+81-52-762-6111

a-kataoka@aichi-cc.jp

Recruiting

Feb. 07, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) The patient has been diagnosed with the first locoregional recurrence (LRR) after undergoing definitive treatment with total mastectomy or partial mastectomy for primary breast cancer. The recurrence 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 locoregional recurrence (LRR) confirmed by biopsy, surgical specimen, or cell block prepared from cytology, meeting all of the following criteria:
(i) Pathologically confirmed as invasive breast cancer or diagnosed as breast cancer in a cell block from cytology (if only a cell block is available, the initial primary breast cancer must be diagnosed as invasive).
(ii) Expression of hormone receptors (HR) is positive.
(iii) HER2 expression is negative.
-If different subtypes are diagnosed in different specimens for a single lesion, prioritize diagnosis in the following order: (1) surgical specimen, (2) biopsy specimen, (3) cell block from cytology.
-If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.

(3) All LRRs must have undergone one of the following definitive treatments:
(i) Completely resected with no residual tumor (radiotherapy before or after surgery is permitted).
(ii) Radiotherapy administered for microscopically positive margins (no macroscopic residual tumor, but cancer cells are exposed at the resection margin microscopically).
(iii) Radiotherapy determined to be curative by the radiation oncologist for inoperable regional lymph node recurrence (such as supraclavicular lymph node, internal mammary lymph node, or level III axillary lymph node recurrence).

(4) No prior diagnosis of distant metastasis of breast cancer.

(5) Imaging assessment before registration confirms no lymph nodes with a short diameter of >=10 mm and no distant metastasis.

(6) Age is 18 years or older on the date of registration.

(7) ECOG performance status (PS) is 0 or 1.

(8) Allows the administration of chemotherapy for LRR.

(9) The patient dose not have bilateral breast cancer.

(10) No prior treatment history with CDK4/6 inhibitors.

(11) Written consent has been obtained from the patient for participation in this clinical trial.

(1) Active double cancer (synchronous malignancies requiring treatment).
(2) Presence of an infectious disease requiring systemic therapy.
(3) Fever of 38.0 degrees or higher 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) Mental illness or psychiatric symptoms that interfere with daily life and are deemed to make participation in the trial difficult.
(6) Continuous systemic administration (oral or intravenous) of steroid drugs equivalent to 10 mg/day or more of prednisolone, or other immunosuppressive agents.
(7) Presence of unstable angina (angina that developed or worsened within the past three weeks) or a history of myocardial infarction within the past six months.
(8) Uncontrolled hypertension.
(9) Uncontrolled diabetes mellitus despite continuous use of insulin or oral hypoglycemic agents.
(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 diagnosed by chest CT.

Both

Locoregional recurrence of hormone receptor-positive, HER2-negative breast cancer

Arm A: Endocrine therapy
Arm B: Endocrine therapy + Abemaciclib
In both arms, treatment with endocrine therapy will be given for up to 5 years. In the arm B, treatment with abemaciclib will be given for up to 2 years or until discontinuation criteria are met.

Invasive disease-free survival

Distant recurrence-free survival
Breast cancer-specific survival
Overall survival
Adverse event rate
Serious adverse event rate

+81-4-7133-1111

Dec. 12, 2024

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