Combining radiotherapy and chemotherapy with Toripalimab for advanced breast cancer

A Phase II,Single-arm,Multicenter Study of Radiotherapy Followed by Chemotherapy Combined With Toripalimab Immunotherapy in Local Advanced HR-positive,HER2-negative Breast Cancer.

This study is testing if combining radiotherapy and chemotherapy with a new drug called Toripalimab can help people with advanced breast cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Drugs / interventions: chemotherapy, immunotherapy, terriplizumab, triplimab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06705127 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of neoadjuvant radiotherapy followed by chemotherapy combined with Toripalimab in patients with locally advanced HR-positive, HER2-negative breast cancer. The study aims to enroll approximately 30 participants who meet specific criteria, including age and cancer staging. By exploring the potential of this combination therapy, the trial seeks to improve treatment outcomes for patients with advanced breast cancer, particularly in regions with increasing incidence rates. The approach leverages recent insights into the tumor microenvironment and immunotherapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with locally advanced HR-positive, HER2-negative breast cancer who have not received prior treatment.

Not a fit: Patients with confirmed metastatic breast cancer or those who have previously undergone systemic treatment for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the therapeutic outcomes for patients with locally advanced HR-positive, HER2-negative breast cancer.

How similar studies have performed: While this approach is innovative, similar studies exploring the combination of radiotherapy and immunotherapy have shown promising results, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;
2. Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67\>20%;
3. T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;
4. No previous treatment;
5. ECOG PS 0-1 score;
6. The subject or legal representative has been informed of the nature of the study, understands the protocol, is able to guarantee compliance, and signs the informed consent

Exclusion Criteria:

1. Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components;
2. Currently participating in and receiving other research treatment;
3. Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.;
4. Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;
5. Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening;
6. Uncontrolled or symptomatic hypercalcemia (\> 1.5mmol/L calcium ion or calcium \> 12mg/dL or corrected serum \> ULN);
7. Clinically uncontrolled active infections, including but not limited to acute pneumonia;
8. Uncontrollable major seizures or superior vena cava syndrome;
9. previous or current co-occurrence of other malignant tumors (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder carcinoma and other in situ cancers that have been treated radically and have no evidence of disease recurrence);
10. Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, chest CT screening found evidence of active pneumonia or other moderate to severe lung diseases that seriously affect lung function;
11. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
12. Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within the first 6 months of enrollment;
13. received systemic immunosuppressive drugs (i.e. use of corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years prior to study initiation;
14. Received live virus vaccine within 4 weeks prior to study initiation;
15. Patients who have previously received allogeneic stem cells or parenchymal organ transplants;
16. Pregnant or lactating women or women who have the possibility of becoming pregnant have tested positive for pregnancy before the first drug use, and patients who are fertile but do not want to take contraceptive measures or their sexual partners do not want to take contraceptive measures
17. Any other clinically significant illness or condition that the investigator believes could affect adherence to the protocol (such as a history of mental illness or substance abuse), prevent the patient from benefiting from the clinical study, or prevent the patient from signing informed consent (such as drug use and substance abuse), or make participation in the clinical study inappropriate (including but not limited to: Abnormal laboratory results, clinical active diverticulitis, abdominal abscess, intestinal obstruction, and peritoneal metastases).

Where this trial is running

Hangzhou, Zhejiang

• the First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Peifen Fu, MD — Zhejiang University
• Study coordinator: Peifen Fu, MD

Conditions: HR-positive,HER2-negative Breast Cancer, Local Advanced, Toripalimab, Radiotherapy, Neoadjuvant