SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Luminal-type Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 28, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

September 1, 2027

Conditions
Breast Cancer
Interventions
DRUG

Lvonescimab (AK112)

"8Gy×3 SBRT (continuous irradiation) to irradiate the primary lesion (for patients with axillary lymph node metastasis) or 6Gy×3 SBRT (continuous irradiation) to irradiate the primary lesion and axillary lymph node metastasis (for patients without axillary lymph node metastasis) will be administered at first.~Then the first cycle of chemotherapy + AK112 will be given within 24 hours after the end of SBRT.~The total eight cycles of preoperative chemotherapy combined with immunotherapy will be administered.~Surgical resection will be performed within 4-6 weeks after the completion of the eighth cycle.~The chemotherapy regimen consists of: Four cycles of doxorubicin 50 mg/m² (Q3W) + cyclophosphamide 600 mg/m² (Q3W), followed by Four cycles of albumin-bound paclitaxel 125 mg/m², Day 1 and Day 8 (every 28 days).~The immunotherapy drug used is Ivonescimab (AK112) (20mg/kg) , administered every 3 weeks concurrently with chemotherapy for 8 cycles."

Trial Locations (1)

430079

RECRUITING

Hubei Cancer Hospital, Wuhan

All Listed Sponsors
lead

Hubei Cancer Hospital

OTHER