Actively Recruiting
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-02-21
260
Participants Needed
1
Research Sites
648 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
CONDITIONS
Official Title
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 65 18 years-old at the time of consent to participate this trial
- Stage II - III primary triple negative breast cancer patients (TNBC), defined as ER �3C=1%, PR �3C=1%; HER2 receptor IHC=1, or IHC=2 and FISH negative
- Positive ctDNA after curative surgery and/or adjuvant chemotherapy
- ECOG performance status 0-2
- Patient agrees to receive adjuvant radiotherapy if indicated by institutional guidelines
- Patient receives adjuvant chemotherapy according to NCCN guidelines
- Available tumor tissue from the surgical specimen for next generation sequencing (NGS)
- Patient agrees to give blood samples for ctDNA tests every 3 months for 5 years
You will not qualify if you...
- Previous treatment with any PD1 or PDL1 blocking therapy
- Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the trial
- Presence of distant metastases beyond regional lymph nodes (stage IV breast cancer)
- Participation in another interventional clinical trial
- Concurrent invasive malignancy or prior invasive malignancy treated within 3 years before randomization
- Autoimmune disease preventing use of camrelizumab
- Other severe or uncontrolled medical conditions that pose safety risks or affect protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
Actively Recruiting
Research Team
S
Shunying Li, MD
CONTACT
Q
Qiang Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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