Actively Recruiting
SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)
Led by Hubei Cancer Hospital · Updated on 2024-12-02
51
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 triple-negative breast cancer（TNBC）patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of TNBC 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. Cadonilimab (AK104) is an PD-1/CTLA-4 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+AK104+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.
CONDITIONS
Official Title
SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with histologically confirmed triple-negative breast cancer (ER-/PR-/HER2-) with tumor mass larger than 2cm, or axillary lymph node metastasis, or large tumor to breast volume ratio making breast conservation difficult
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function as defined by specific laboratory test thresholds before enrollment
You will not qualify if you...
- Received chemotherapy, targeted therapy, or radiation therapy within 12 months before starting study treatment
- History of solid organ or blood system transplantation
- Myocardial infarction or poorly controlled arrhythmia within 6 months before starting study treatment
- Severe heart failure (NYHA class III-IV) or reduced heart function (LVEF <50%)
- Poorly controlled high blood pressure or previous hypertensive crisis
- Active infections such as HIV, tuberculosis, or severe lung diseases affecting lung function
- Known active or suspected autoimmune diseases requiring systemic immunosuppressive therapy
- Recent live vaccine within 28 days before starting study treatment (inactivated flu vaccine allowed)
- Use of systemic corticosteroids or immunosuppressive drugs above specified doses within 14 days before starting study treatment
- Positive tests for active hepatitis B or C infections
- Prior treatment with immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4
- Participation in another clinical trial or planned start of study treatment less than 14 days after previous trial
- Major surgery within 4 weeks before starting study treatment
- Pregnant or breastfeeding women
- History of severe allergies to monoclonal antibodies or study drugs
- History of substance abuse or drug use
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here