Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine |
|
| B | Active Comparator | ctDNA positive, non-pCR Intervention: capecitabine(standard care) |
|
| C | Experimental | ctDNA positive, pCR Intervention: capecitabine |
|
| D | No Intervention | Follow up(standard care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200mg, q3w, for 1 year |
| |
| capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| 5 years Disease free survival(DFS) | From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 5 years overall survival(OS) | From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy | 60 months |
| pathological complete remission(pCR) rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunying Li, MD | Contact | +86-15915939702 | lishunying@foxmail.com | |
| Yudong Li, MD | Contact | 020-34071156 | 910870698@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Liu, MD | Sunyat-sen Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunyat-sen Memorial Hospital | Recruiting | Guandong | Guangdong | China |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
600-750 mg/m2 PO Bid,continuous, for 1 year |
|
pathological complete remission |
| 12 months |
| brain metastasis rate | The percentage of patients who develop brain metastasis | 60 months |
| objective response rate(ORR) | The percentage of patients who achieved PR+CR | 12 months |
| Number of Patients with Adverse Events as a Measure of Safety and Tolerability | To determine the toxicities associated with tislelizumab in this population | 12 months |
| 10 years DFS | To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy | 120 months |
| 10 years OS | To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy | 120 months |
| Relapse and metastasis rate | The percentage of patients who develop brain metastasis any relapse or metastasis | 24 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |