Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.

Last updated: November 24, 2024
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Stereotactic Body Radiation Therapy (SBRT)

TORIPALIMAB INJECTION(JS001 )

Clinical Study ID

NCT06705127
2024-114
  • Ages 18-75
  • All Genders

Study 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

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 informedconsent

Exclusion

Exclusion Criteria:

  1. Those who are known to be allergic to recombinant humanized antiPD-1 monoclonalantibody drugs and their components;

  2. Currently participating in and receiving other research treatment;

  3. Previously received systematic treatment for breast cancer, including systematicchemotherapy, 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 havereceived 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 acutepneumonia;

  8. Uncontrollable major seizures or superior vena cava syndrome;

  9. previous or current co-occurrence of other malignant tumors (except for non-melanomaskin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma insitu, superficial bladder carcinoma and other in situ cancers that have been treatedradically 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 othermoderate 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 orhigher heart failure, unstable angina, unstable arrhythmia, myocardial infarction orcerebrovascular accident within the first 6 months of enrollment;

  13. received systemic immunosuppressive drugs (i.e. use of corticosteroids orimmunosuppressive drugs) for any active autoimmune disease within 2 years prior tostudy initiation;

  14. Received live virus vaccine within 4 weeks prior to study initiation;

  15. Patients who have previously received allogeneic stem cells or parenchymal organtransplants;

  16. Pregnant or lactating women or women who have the possibility of becoming pregnanthave tested positive for pregnancy before the first drug use, and patients who arefertile but do not want to take contraceptive measures or their sexual partners donot want to take contraceptive measures

  17. Any other clinically significant illness or condition that the investigator believescould affect adherence to the protocol (such as a history of mental illness orsubstance abuse), prevent the patient from benefiting from the clinical study, orprevent the patient from signing informed consent (such as drug use and substanceabuse), or make participation in the clinical study inappropriate (including but notlimited to: Abnormal laboratory results, clinical active diverticulitis, abdominalabscess, intestinal obstruction, and peritoneal metastases).

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Stereotactic Body Radiation Therapy (SBRT)
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
July 01, 2028

Study Description

Breast cancer is the first malignant tumor in women worldwide, and its incidence is still increasing year by year. Compared with developed countries in Europe and the United States, although the incidence of breast cancer in China is low, it is showing a rapid growth trend, and due to practical factors such as large population base and unbalanced distribution of medical resources, the overall stage of initial diagnosis of breast cancer patients in China is later than that in developed countries in Europe and the United States, and the proportion of local advanced and advanced breast cancer patients is higher. As the overall prognosis of early breast cancer patients is good, how to further improve the therapeutic effect of locally advanced and advanced breast cancer patients has become the main pass to improve the overall prognosis of breast cancer. In the comprehensive treatment strategy of breast cancer, radiotherapy is an indispensable part of local treatment. In the past, the understanding of the antitumor effect of radiotherapy was mainly limited to the dormancy or lytic death of tumor cells caused by DNA damage in tumor cells caused by X-ray. However, in recent years, with the deepening of research on tumor microenvironment and immunotherapy, researchers have gradually revealed the remodeling effect of radiotherapy on tumor microenvironment. We designed this clinical study of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab immunotherapy to explore the effect of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab on postoperative pCR rate and prognosis of patients with locally advanced HR-positive and HER2-negative breast cancer.

Connect with a study center

  • the First Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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