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

Not yet recruiting

• Conditions: Recurrence; Breast Cancer

• Registration Number: NCT04972448
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
invasive disease-free survival (IDFS)	5 years	defined as time between treatment and the time of invasive disease occurred
recurrence free survival (RFS)	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

Secondary Outcome Measures

Name	Time	Method
distance metastasis-free interval (DMFI)	5 years	defined as time between treatment and the time of distant metastases, or death
local-regional recurrence-free interval (LRFI)	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
overall survival (OS)	5 years	defined as time between treatment and the time of death occurred