NCT06705127 Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
| NCT ID | NCT06705127 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | HR-positive,HER2-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Peifen Fu, MD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06705127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HR-positive,HER2-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06705127 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06705127 currently recruiting?
Yes, NCT06705127 is actively recruiting participants. Contact the research team at fupeifen@zju.edu.cn for enrollment information.
Where is the NCT06705127 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06705127 clinical trial?
NCT06705127 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Peifen Fu, MD at Zhejiang University. The trial plans to enroll 30 participants.
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