Combining chemotherapy with Toripalimab for treating triple negative breast cancer

Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)

This study is testing if combining chemotherapy with Toripalimab can help women with triple negative breast cancer respond better to treatment before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Toripalimab
• Locations: 13 sites (Nanchang, Jiangxi and 12 other locations)
• Trial ID: NCT06682195 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of neoadjuvant chemotherapy combined with Toripalimab in women with triple negative breast cancer (TNBC). It is a prospective, single-arm, multi-center phase II trial aimed at assessing the pathologic complete response (PCR) and monitoring adverse events. Additionally, the study will analyze disease-free survival (DFS), progression-free survival (PFS), and objective response rate (ORR) among participants. The trial includes female patients aged 18-70 with confirmed TNBC and specific tumor characteristics.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-70 with histologically confirmed triple negative breast cancer and specific tumor characteristics.

Not a fit: Patients with non-triple negative breast cancer or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with triple negative breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating TNBC.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-70 years old;
2. ECOG score is 0-1 points;
3. Histologically proven tumors \>1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;
4. All patients had triple negative breast cancer confirmed by histopathology;
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

Nanchang, Jiangxi and 12 other locations

• Nanchang People's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University — Hangzhou, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Jinhua Municipal Central Hospital — Jinhua, China (Recruiting)
• Nantong First People's Hospital — Nantong, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Shanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Not_yet_recruiting)
• Xinjiang Medical University Affiliated Cancer Hospital — Xinjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Zhijun Dai

Conditions TNBC, Triple Negative Breast Cancer; Triple negative breast cancer; Toripalimab; Adjuvant Treatment