SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

November 28, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

September 1, 2027

Conditions
Breast Cancer
Interventions
DRUG

Cadonilimab (AK104)

8Gy\*3 SBRT to irradiate the primary lesion (without axillary lymph node metastasis) or 6Gy\*3 SBRT irradiation to irradiate the primary lesion and axillary lymph node metastasis will be administered at first. And then the first cycle of chemotherapy+AK104 given within 24 hours of the end of SBRT. The total eight cycles of preoperative chemotherapy combined with immunotherapy were administered. Surgical resection was performed within 4-6 weeks after the completion of the eighth cycle of chemotherapy combined with immunotherapy. The chemotherapy regimen consisted of: Four cycles of doxorubicin 50mg/m2 (Q3W) + cyclophosphamide 600mg/m2 (Q3W) were administered, followed by four cycles of sequential albumin paclitaxel (125 mg/m2, d1, d8) and carboplatin (AUC=6, d1, Q3W) for 4 cycles. Postoperative completion of 9 cycles of immunotherapy was continued ± the need for postoperative adjuvant radiotherapy was confirmed based on the patient's preoperative status.

Trial Locations (1)

430079

RECRUITING

Hubei Cancer Hospital, Wuhan

All Listed Sponsors
lead

Hubei Cancer Hospital

OTHER