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

NCT ID: NCT04972448

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2025-11-30

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.

Conditions

Breast Cancer; Recurrence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group1

Chemotherapy+endocrine therapy+radiotherapy

No interventions assigned to this group

Group2

Chemotherapy+endocrine therapy

No interventions assigned to this group

Group3

endocrine therapy+radiotherapy

No interventions assigned to this group

Group4

endocrine therapy

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiajia Wang, MD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Central Contacts

Lei Lei, MD

Role: CONTACT

leilei1241@163.com

13750802564

Other Identifiers

ZhejiangCH-0709

Identifier Type: -

Identifier Source: org_study_id