Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06402435

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

Led by Hubei Cancer Hospital · Updated on 2025-07-02

50

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Histologically confirmed hormone receptor-positive, HER2-negative breast cancer
  • Tumor size greater than 2 cm, or axillary lymph node metastasis, or breast-conserving surgery difficult due to tumor-to-breast volume ratio
  • ECOG performance status of 0 or 1
  • Adequate blood counts: WBC ≥ 2.0×10⁹/L, ANC ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L
  • Liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN), ALT and AST ≤ 3× ULN
  • Renal function: serum creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min
  • Coagulation parameters within acceptable limits: APTT ≤ 1.5× ULN, PT or INR ≤ 1.5× ULN
  • Treatment-naïve and voluntarily provide written informed consent
Not Eligible

You will not qualify if you...

  • Received chemotherapy, targeted therapy, or radiotherapy within 12 months before first study drug dose
  • History of myocardial infarction or uncontrolled arrhythmias (QTc ≥ 470 ms) within 6 months
  • NYHA class III-IV heart failure, LVEF less than 50%, or uncontrolled hypertension (systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg)
  • Active HIV, tuberculosis, interstitial lung disease, severe lung impairment, or autoimmune diseases requiring systemic immunosuppression
  • Received live vaccines within 28 days before first dose (inactivated influenza vaccine allowed)
  • Use of systemic corticosteroids >10 mg/day prednisone equivalent or immunosuppressants within 14 days before first dose, except short-term or low-dose corticosteroids, localized treatments, and adrenal replacement therapy
  • Active infections requiring systemic therapy within 14 days prior to enrollment
  • Hepatitis B or C with detectable viral DNA or RNA
  • Prior treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies)
  • Participation in another clinical trial within 14 days
  • Major surgery within 4 weeks before first dose (except biopsy)
  • Severe allergic reactions to monoclonal antibodies or study drug components
  • Pregnancy or breastfeeding
  • Active psychiatric disorders or substance abuse history
  • Other conditions deemed inappropriate by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

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Research Team

X

Xinjun Liang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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