Breast Cancer, Recurrence
Conditions
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.
Interventions
None listed
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| invasive disease-free survival (IDFS) | 5 years | defined as time between treatment and the time of invasive disease occurred |
| recurrence free survival (RFS) | 5 years | defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 5 years | defined as time between treatment and the time of death occurred |
| distance metastasis-free interval (DMFI) | 5 years | defined as time between treatment and the time of distant metastases, or death |
| local-regional recurrence-free interval (LRFI) | 5 years | defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred |
Contacts
Primary ContactLei Lei, MD
Outcome results
None listed