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

NCT06705127 | Recruiting Phase 2

• 1 other identifier: 2024-114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HR-positive,HER2-negative Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response（pCR）

  pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.

  Up to12 months

Study Arms (1)

Toripalimab treatment group

EXPERIMENTAL

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. 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.

Drug: TORIPALIMAB INJECTION(JS001 ); Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

TORIPALIMAB INJECTION(JS001 ) DRUG

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.

Also known as: Epirubicin, cyclophosphamide, nab-paclitaxel

Toripalimab treatment group

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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

Toripalimab treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

Epirubicin; Cyclophosphamide; 130-nm albumin-bound paclitaxel; Radiosurgery

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Peifen Fu, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Senxiang Yan, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peifen Fu, MD

CONTACT

0571-87236852; fupeifen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 26, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)