Triple-negative Breast Cancer
Conditions
Brief summary
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Interventions
DRUGTislelizumab
200mg, q3w, for 1 year
DRUGcapecitabine
600-750 mg/m2 PO Bid，continuous, for 1 year
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \< 2.0 or \< 6 copies per cell. * Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll. * ctDNA positive at baseline, after NAC or after surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Written informed consent to provide research blood samples and tumor samples * Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection * No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis
Exclusion criteria
* Previously participated in other interventional trials * Previous malignancy within 3 years of breast cancer diagnosis * Pregnancy or breastfeeding * No written consent * Unable to receive standard NAC and subsequent radiotherapy(if needed) * Active autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 years Disease free survival(DFS) | 60 months | From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete remission(pCR) rate | 12 months | pathological complete remission |
| brain metastasis rate | 60 months | The percentage of patients who develop brain metastasis |
| objective response rate(ORR) | 12 months | The percentage of patients who achieved PR+CR |
| 5 years overall survival(OS) | 60 months | From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy |
| 10 years DFS | 120 months | To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy |
| 10 years OS | 120 months | To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy |
| Relapse and metastasis rate | 24 months | The percentage of patients who develop brain metastasis any relapse or metastasis |
| Number of Patients with Adverse Events as a Measure of Safety and Tolerability | 12 months | To determine the toxicities associated with tislelizumab in this population |
Countries
China
Contacts
Primary ContactShunying Li, MD
Backup ContactYudong Li, MD
Outcome results
None listed