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New treatment option for HR-positive,HER2-negative Breast Cancer
Official title Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
ClinicalTrials.gov ID: NCT06705127
What this study is testing
What is TORIPALIMAB INJECTION(JS001 )?
TORIPALIMAB INJECTION(JS001 ) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hr-positive,her2-negative breast cancer.
Also referred to as Epirubicin, cyclophosphamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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);
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.