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

NCT04972448 | Unknown

• 1 other identifier: ZhejiangCH-0709
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• overall survival (OS)

  5 years

• distance metastasis-free interval (DMFI)

  5 years

• local-regional recurrence-free interval (LRFI)

  5 years

Study Arms (4)

Group1

Chemotherapy+endocrine therapy+radiotherapy

Group2

Chemotherapy+endocrine therapy

Group3

endocrine therapy+radiotherapy

Group4

endocrine therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiajia Wang, MD

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Lei Lei, MD

CONTACT

13750802564; leilei1241@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 22, 2021

Record last verified: 2021-07