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NCT06402435Not yet recruiting

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

A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Ivonescimab Neoadjuvant Therapy for Luminal-type Breast Cancer
Hubei Cancer HospitalPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Lvonescimab (AK112)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Hubei Cancer Hospital
Timeline & enrollment
Phase
Phase 2
Start date
Sep 01, 2024
End date
Sep 01, 2027
Enrollment
50 participants
Primary outcome

Complete pathologic remission (pCR) rate

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.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06402435
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06402435 through Pure Global AI's free database. This Phase 2 trial is sponsored by Hubei Cancer Hospital and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.