Neoadjuvant chemotherapy with sintilimab and bevacizumab for triple-negative breast cancer

Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for Triple Negative Breast Cancer:A Prospective, Single-Arm, Multicenter Clinical Study (NEOTORCII-BREASTO7)

This trial will try adding the immunotherapy drug sintilimab and the blood‑vessel blocker bevacizumab to pre-surgery chemotherapy for women with stage II–III triple‑negative breast cancer to see if more tumors disappear completely before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Sintilimab, Bevacizumab
• Locations: 2 sites (Hefei and 1 other locations)
• Trial ID: NCT07351487 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multicenter phase II trial giving sintilimab and bevacizumab together with standard neoadjuvant chemotherapy to patients with stage II–III triple‑negative breast cancer. The primary endpoint is pathologic complete response (pCR) and safety, with secondary endpoints including event‑free survival (EFS), objective response rate (ORR), and radiologic complete response (rCR). Eligible patients are female, 18–70 years old, with histologically confirmed TNBC and ECOG 0–1 and must have adequate organ function; PD‑L1 will be reported using the 22C3 assay. Treatments and follow‑up occur at participating hospitals in China prior to planned surgery.

Who should consider this trial

Good fit: Women aged 18–70 with histologically confirmed stage II–III triple‑negative breast cancer, ECOG 0–1, adequate organ function, and who are candidates for neoadjuvant chemotherapy are the ideal participants.

Not a fit: Patients with ER/PR or HER2 positive tumors, metastatic disease, poor organ function, ECOG >1, or those unable to use effective contraception during treatment are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this combination could raise the rate of complete tumor disappearance before surgery and may improve event‑free survival for patients with stage II–III TNBC.

How similar studies have performed: Adding PD‑1/PD‑L1 inhibitors to neoadjuvant chemotherapy has improved pCR in randomized trials such as KEYNOTE‑522, but combining PD‑1 blockade with bevacizumab in this setting is less well established.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-70 years old;
2. ECOG score is 0-1 points;
3. Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;
4. 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;
5. 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 PD-L1 antibody site as 22C3.
6. The functional level of major organs must meet requirements
7. 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 after a single administration.
8. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

Exclusion Criteria:

1. Stage IV breast cancer.
2. Inflammatory breast cancer.
3. 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 carcinoma.
4. 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 checkpoint inhibitor therapy, etc.
5. 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.
6. 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 atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg).

7\. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

8\. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment \[HBV-DNA test negative or\<50IU/ml\] and cured hepatitis C patients \[HCV RNA test negative\]).

9\. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.

10\. Individuals with a known history of allergies to the components of this medication regimen.

11\. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.

12\. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

Where this trial is running

Hefei and 1 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhijun Dai

Conditions TNBC - Triple-Negative Breast Cancer; TNBC; Sintilimab; Bevacizumab