Trial Title:
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
NCT ID:
NCT06611813
Condition:
HR+/HER2- Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Toripalimab
Adjuvant Chemotherapy
HR-positive HER2-negative
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adjuvant treatment combined with Toripalimab
Description:
Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100
mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide,
starting from the first day of the third week, for a total of 12 weeks. Paclitaxel,
administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks.
During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of trastuzumab:
intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative and
postoperative adjuvant therapy for a total of 1 year.
Arm group label:
Adjuvant treatment combined with Toripalimab
Intervention type:
Drug
Intervention name:
HR+ HER2 breast cancer
Description:
During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of trastuzumab:
intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative and
postoperative adjuvant therapy for a total of 1 year.
Arm group label:
Adjuvant treatment combined with Toripalimab
Summary:
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 Adjuvant
treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant
chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and
types of adverse events. The secondary study objective is to observe and evaluate the
disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response
Rate(ORR)
Detailed description:
1. Breast cancer is the most common malignant tumor among women worldwide, with 2.3
million women suffering from it every year. In China, the incidence rate of breast
cancer is increasing year by year, with about 400000 new cases every year, which
seriously threatens the life and health of women in China. Study population:
participants with HR+/HER2- breast cancer confirmed by postoperative pathology
according to American Joint Committee on Cancer (AJCC) / Union for International
Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging classification.
2. Sample size: single arm design was used in this study and 50 participants were
estimated to be enrolled.
3. Histologically confirmed invasive breast cancer with tumor diameter>1cm
(T1c-3; N0-3; M0). All patients were pathohistologically confirmed as HR+/HER2-
breast cancer. According to the breast cancer diagnosis and treatment guidelines and
specifications of the Chinese Society of Clinical Oncology, Luminal B is divided
into Luminal B (HER2 negative) and Luminal B (HER2 positive). Luminal B (HER2
negative) is ER/PR positive, HER2 negative and Ki-67 proliferation index is high or
PR low expression. Luminal type B (HER2 positive) is ER/PR positive, HER2 positive
(protein overexpression or gene amplification), and Ki-67 in any state. Therefore,
HR+/HER2- breast cancer is a Luminal type breast cancer patient excluding HER2+.
4. Chemotherapy Phase 1: Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide,
intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal
doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the third
week, for a total of 12 weeks.
Chemotherapy Phase 2: Paclitaxel, administered intravenously at a dose of 260 mg/m2
every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and
postoperative adjuvant therapy, use of trastuzumab: intravenous infusion of 240 mg,
once every 3 weeks, combined with preoperative and postoperative adjuvant therapy
for a total of 1 year.
5. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will
monitor carefully to determine whether or not they are within the expected range.
Investigators will also conduct a thorough examination and adopt an appropriate
system to take any necessary measures to deal with AEs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients aged 18-75 years old;
2. ECOG score is 0-1 points;
3. 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. According to the breast
cancer diagnosis and treatment guidelines and specifications of the Chinese Anti
Cancer Association (2021 version), Luminal B is divided into Luminal B (HER2
negative) and Luminal B (HER2 positive). Luminal B (HER2 negative) is ER/PR
positive, HER2 negative and Ki-67 proliferation index is high or PR low expression.
Luminal type B (HER2 positive) is ER/PR positive, HER2 positive (protein
overexpression or gene amplification), and Ki-67 in any state. Therefore, HR+/HER2-
breast cancer is a Luminal type breast cancer patient excluding HER2+.
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.
4. 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:
1. 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
2. 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) and creatinine
(Cr) are less than 1.5 × ULN.
3. Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.
4. 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 period and in the study
treatment, the final use effective contraceptive methods for at least 6 months after
a single administration.
6. 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Yu
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tong Liu
Phone:
+86 0451 86298000
Email:
915389289@qq.com
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Chen
Facility:
Name:
Nanchang People's Hospital
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yili Wang
Facility:
Name:
Xinjiang Medical University Affiliated Cancer Hospital
Address:
City:
Wulumuqi
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongtao Li
Facility:
Name:
Shaanxi Provincial Cancer Hospital
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaomin Yang
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Huafeng Kang
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Pengwei Lv
Start date:
October 2024
Completion date:
October 2029
Lead sponsor:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611813
