Clinical trial NCT04972448: RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Recurrence
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer

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.


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.

Primary outcomes:
measure: invasive disease-free survival (IDFS)
timeFrame: 5 years
measure: recurrence free survival (RFS)
timeFrame: 5 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 5 years
measure: distance metastasis-free interval (DMFI)
timeFrame: 5 years
measure: local-regional recurrence-free interval (LRFI)
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiajia Wang, MD
role: STUDY_CHAIR
References: