Recurrence Risk Evaluation by 21-gene Detection

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Relationship and Consistency Analysis

Treatments: Diagnostic Test: recurrence risk evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT03841266

KY2019

Details and patient eligibility

About

Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. breast cancer in stage I-III, tumor size>0.5cm
2. lymph nodes negative
3. hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）
4. HER2 negative（IHC 0 or +， FISH negative）
5. receive endocrine therapy only
6. enough FFPE samples within 10 years（3~6 10μm ）
7. patients with integrated medical records

Exclusion criteria

1. Tumor cells <5%
2. Isolated RNA<500ng