Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
With
Jiangsu HengRui Medicine Co., Ltd.
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
