Breast Cancer
Conditions
Keywords
MRD, breast cancer, adjuvant therapy
Brief summary
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.
Interventions
In this study, peripheral blood samples would be collected before adjuvant chemotherapy, after adjuvant chemotherapy and every 3 months thereafter until 2 years after surgery.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed * Age ≥18 years old * Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions: 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4; 2. HER2-positive breast cancer, lymph node metastasis≥4; 3. Triple negative breast cancer, the number of lymph node metastases ≥ 1; * ECOG 0-1 * Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance
Exclusion criteria
* Confirmed distant metastases site * History of other malignancy * Psychopaths or other reasons unable to comply with treatment * Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments * HIV carrier or HBC/HCV infected * Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | 5 years after surgery | Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years after surgery | Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause |
| Lead time | 2 years after surgery | Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases |
Countries
China
Outcome results
None listed