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New treatment option for HR+/HER2- Breast Cancer
Official title Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
ClinicalTrials.gov ID: NCT06977893
What this study is testing
What is Neoadjuvant Chemotherapy in Combination with Toripalimab?
Neoadjuvant Chemotherapy in Combination with Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hr+/her2- breast cancer.
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
- Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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, women only
You may be able to join if
- Female patients aged 18-75 years old;
- ECOG score is 0-1 points;
- breast cancer meets the following standards: Histologically confirmed invasive breast cancer with tumor diameter\>1cm (T1c-3; N0-3; M0). All patients...
- The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of...) Using...
- Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; platelet count (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater...
You likely can't join if
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as...
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment...
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or...
- Serious heart disease or discomfort, including but not limited to the following diseases: 1) Diagnosed history of heart failure or systolic...
See the full eligibility criteria
- Female patients aged 18-75 years old;
- ECOG score is 0-1 points;
- breast cancer meets the following standards: Histologically confirmed invasive breast cancer with tumor diameter\>1cm (T1c-3; N0-3; M0). All patients were pathohistologically confirmed as HR+/HER2- breast cancer...
- The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of...) Using leukocyte and platelet boosting drugs:
- Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; platelet count (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater than 90g/L; Lymphocyte count ≥ 1.5 × 109/L
- Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanine aminotransferase ALT and aspartate levels are less than 1.5 × ULN; Alkaline phosphatase is less than 2.5 × ULN; Urea nitrogen/ Urea (BUN/UREA)...
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.
- 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment...
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell...
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune...
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
- Serious heart disease or discomfort, including but not limited to the following diseases: 1) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%). 2) High risk uncontrolled arrhythmias, such...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
- Harbin, China
- Hefei, China
- Jinhua, China
- Nanchang, China
- Nantong, China
- Shanghai, China
- Ürümqi, China
- Xi'an, China
- Zhengzhou, 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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China; Harbin, China; Hefei, China; Jinhua, China; Nanchang, China; Nantong, China and 4 more location(s). 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.