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

University of Chinese Academy Sciences

Status

Not yet enrolling

Conditions

Breast Cancer

Recurrence

Study type

Observational

Funder types

Other

Identifiers

NCT04972448

ZhejiangCH-0709

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.