Status:
RECRUITING
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 hi...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years-old at the time of consent to participate this trial
- Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER \<=1%, PR \<=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
- positive ctDNA after curative surgery and/or adjuvant chemotherapy
- ECOG 0-2
- If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
- Patient receives adjuvant chemotherapy according to the NCCN guidelines
- Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
- Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years
Exclusion
- Patient has previously received any PD1/PDL1 blockage treatment
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
- Patient participates another interventional clinical trial
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
- Patient with autoimmune disease preventing the use of camrelizumab
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04803539
Start Date
April 1 2021
End Date
September 1 2033
Last Update
February 21 2023
Active Locations (1)
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1
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China