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New treatment option for TNBC - Triple-Negative Breast Cancer
Official title Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
ClinicalTrials.gov ID: NCT07351487
What this study is testing
What is Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab?
Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tnbc - triple-negative 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
- This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events.
- 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, women only
You may be able to join if
- Female patients aged 18-70 years old;
- ECOG score is 0-1 points;
- Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;
- ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is...
- Pathological examination of PD-L1 expression: The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor...
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 18-70 years old;
- ECOG score is 0-1 points;
- Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;
- ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC;
- Pathological examination of PD-L1 expression: The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected...
- The functional level of major organs must meet requirements
- For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months...
- Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
- 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 as...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, China
- Shanghai, 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 Hefei, China; Shanghai, 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.