Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
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.
First Affiliated Hospital of Zhejiang University
30 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
Summary
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.
Eligibility
Inclusion Criteria6
- Age 18-75 years old, gender is not limited;
- Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67>20%;
- T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;
- No previous treatment;
- ECOG PS 0-1 score;
- 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 Criteria17
- Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components;
- Currently participating in and receiving other research treatment;
- Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.;
- Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;
- Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening;
- Uncontrolled or symptomatic hypercalcemia (\> 1.5mmol/L calcium ion or calcium \> 12mg/dL or corrected serum \> ULN);
- Clinically uncontrolled active infections, including but not limited to acute pneumonia;
- Uncontrollable major seizures or superior vena cava syndrome;
- 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);
- 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;
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- 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;
- received systemic immunosuppressive drugs (i.e. use of corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years prior to study initiation;
- Received live virus vaccine within 4 weeks prior to study initiation;
- Patients who have previously received allogeneic stem cells or parenchymal organ transplants;
- 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
- 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).
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Interventions
Drug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1, followed by the first day of each course for 18 cycles, a total of 1 year. Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles. Drug D:albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles.
Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06705127