A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)
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.
• 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