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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04972448
• Other study ID #: ZhejiangCH-0709
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: November 2025

Study information

• Verified date: July 2021
• Source: Zhejiang Cancer Hospital
• Contact: Lei Lei, MD
• Phone: 13750802564
• Email: leilei1241[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	invasive disease-free survival (IDFS)	defined as time between treatment and the time of invasive disease occurred	5 years
Primary	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	overall survival (OS)	defined as time between treatment and the time of death occurred	5 years
Secondary	distance metastasis-free interval (DMFI)	defined as time between treatment and the time of distant metastases, or death	5 years
Secondary	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