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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrence; Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Lei Lei, MD; Phone Number: 13750802564; Email: leilei1241@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group1; Chemotherapy+endocrine therapy+radiotherapy
Group2; Chemotherapy+endocrine therapy
Group3; endocrine therapy+radiotherapy
Group4; endocrine therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Study Chair: Xiajia Wang, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: ZhejiangCH-0709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No