Status:
RECRUITING
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Triple-negative Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2032
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT04501523
Start Date
August 3 2020
End Date
August 1 2032
Last Update
February 21 2023
Active Locations (1)
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1
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China