drugset / Trial / NCT04803539
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
Phase 2/3
Recruiting
260 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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 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.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2028-09-01
- Completion
- 2033-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Capecitabine | Small molecule | 650 mg/m2 | Oral |
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |