Actively Recruiting
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-02-21
460
Participants Needed
1
Research Sites
625 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed triple-negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis
- Received preoperative (neoadjuvant) chemotherapy, including NCCN guideline-recommended regimens or clinical trial therapies
- Positive ctDNA status at baseline, after neoadjuvant chemotherapy, or after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Provided written informed consent to supply research blood and tumor samples
- Willing to undergo blood tests every 3 months and receive 12 months of tislelizumab if randomized to that treatment
- No evidence of distant metastatic disease on staging scans at diagnosis
You will not qualify if you...
- Previous participation in other interventional trials
- History of malignancy within 3 years before breast cancer diagnosis
- Currently pregnant or breastfeeding
- Lack of written informed consent
- Inability to receive standard neoadjuvant chemotherapy and subsequent radiotherapy if needed
- Active autoimmune disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
Actively Recruiting
Research Team
S
Shunying Li, MD
CONTACT
Y
Yudong Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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