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

NCT06402435 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-02

No results posted yet for this study

Summary

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.

Conditions

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.

Sponsors & Collaborators

  • Hubei Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2026-08-31
Completion
2027-09-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402435 on ClinicalTrials.gov