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

Zhejiang Cancer Hospital0 sites500 target enrollmentJuly 2021

ConditionsBreast Cancer Recurrence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 500
Primary Endpoint: invasive disease-free survival (IDFS)
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2021

End Date

November 2025

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old, ≤ 70 years old.
•Eastern Cooperative Oncology Group (ECOG) ≤
•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 pT3N0M
•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 M
•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.

Outcomes

Primary Outcomes

invasive disease-free survival (IDFS)

Time Frame: 5 years

defined as time between treatment and the time of invasive disease occurred

recurrence free survival (RFS)

Time Frame: 5 years

defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred