Combining SBRT, chemotherapy, and AK112 for treating luminal-type breast cancer

A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Ivonescimab Neoadjuvant Therapy for Luminal-type Breast Cancer

This study is testing whether combining a type of radiation therapy, chemotherapy, and a new immunotherapy can help people with luminal-type breast cancer respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Hubei Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Ivonescimab, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06402435 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining stereotactic body radiotherapy (SBRT), chemotherapy, and the immunotherapy agent AK112 in patients with luminal-type breast cancer. The study aims to improve the pathological complete response (pCR) rates, which are crucial for overall survival in this patient population. By leveraging the abscopal effect of SBRT, the trial seeks to enhance the immune response against tumor cells. The inclusion criteria focus on patients with untreated HR+/HER2-negative breast cancer who meet specific tumor size or lymph node involvement criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated HR+/HER2-negative breast cancer and specific tumor characteristics.

Not a fit: Patients with HER2-positive breast cancer or those who have received prior treatment for their breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with luminal-type breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in different cancer types, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

This trial aims to enroll patients who treatment-naïve and voluntarily participate and provide written informed consent; Eligible participants must have histologically confirmed and HR+/HER2-negative breast cancer (HER2 immunohistochemistry 0, 1+, or 2+/FISH-); Patients must meet at least one of the following criteria: (1) tumor size \>2 cm, (2) axillary lymph node metastasis, or (3) intent for breast-conserving surgery, but tumor-to-breast volume ratio makes preservation challenging; Additional eligibility requirements include age ≥18 years, an ECOG performance status of 0-1, and baseline laboratory values within acceptable ranges: white blood cell count (WBC) ≥2.0×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L. Liver function parameters must be within ≤1.5×upper limit of normal (ULN) for total bilirubin (TBIL) and ≤3×ULN for alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Renal function must be preserved, with serum creatinine (Cr) ≤1.5× ULN, or if Cr exceeds this limit, the creatinine clearance rate should be ≥50 mL/min (calculated using the Cockcroft-Gault formula). Coagulation parameters should meet the following thresholds: activated partial thromboplastin time (APTT)≤1.5×ULN and prothrombin time (PT) or international normalized ratio (INR) ≤1.5×ULN.

Exclusion Criteria:

Received chemotherapy, targeted therapy, or radiotherapy within 12 months before the first dose of the investigational drug, or have undergone solid organ or hematologic transplantation; A history of myocardial infarction or uncontrolled arrhythmias (QTc ≥470 ms by Fridericia's formula) within 6 months before the first dose; NYHA class III-IV heart failure, left ventricular ejection fraction (LVEF) \<50%, or uncontrolled hypertension (systolic BP ≥150 mmHg and/or diastolic BP ≥100 mmHg); Patients with active HIV, tuberculosis, interstitial lung disease, severe pulmonary impairment, or autoimmune diseases requiring systemic immunosuppression will also be excluded; Participants must not have received a live vaccine within 28 days prior to the first dose, though inactivated influenza vaccines are permitted. Patients requiring systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 14 days before the first dose will be excluded, except for short-term or low-dose corticosteroids, localized applications, and adrenal replacement therapy; Patients with active infections requiring systemic therapy within 14 days prior to enrollment, hepatitis B or C with detectable viral DNA/RNA, history of 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 the first dose (except for biopsy procedures), severe allergic reactions to monoclonal antibodies or study drug components, pregnancy or lactation, active psychiatric disorders or substance abuse history; Patients who have ceased alcohol consumption may be included. Lastly, investigators may exclude participants based on any other conditions deemed inappropriate for study participation.

Where this trial is running

Wuhan, Hubei

• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xinjun Liang

Conditions Breast Cancer