RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer

Study Overview
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Brief Summary
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This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.

Official Title
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A Clinical Translational Study on the Multi-gene Assays and RecurIndex for Predicting the Breast Cancer Recurrence Risk in Cross-strait Chinese Patients With Early-stage Luminal Breast Cancer

Conditions
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Breast Cancer, Recurrence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, ≤ 70 years old. Eastern Cooperative Oncology Group (ECOG) ≤ 2. Postoperative pathology is clearly diagnosed as invasive breast cancer. Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative. Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue. Stage I-II patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pT1-2N0-1M0 or pT3N0M0. The patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment. Signed an informed consent form. Exclusion Criteria: Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M1. Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases. Other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study. Patients with double breast cancer. Severe/uncontrolled intercurrent diseases/infections. Subjects with allogeneic organ transplants requiring immunosuppressive therapy. Hormone receptors ER and PR are negative (any detectable estrogen and progesterone receptors do not express or express <1%) and/or HER2 overexpression/amplified by FISH detection. Not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br>Chemotherapy+endocrine therapy+radiotherapy | |
| Group2<br>Chemotherapy+endocrine therapy | |
| Group3<br>endocrine therapy+radiotherapy | |
| Group4<br>endocrine therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive disease-free survival (IDFS) | defined as time between treatment and the time of invasive disease occurred | 5 years | 
| recurrence free survival (RFS) | defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | defined as time between treatment and the time of death occurred | 5 years | 
| distance metastasis-free interval (DMFI) | defined as time between treatment and the time of distant metastases, or death | 5 years | 
| local-regional recurrence-free interval (LRFI) | defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred | 5 years |