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Trial Title:
A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer
NCT ID:
NCT05871918
Condition:
HER-2 Positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TCbHP VS ddEC-THP
Description:
The efficacy was evaluated every two cycles, and the effective patients (CR, PR, SD) were
treated with surgery after 6 cycles. If treatment does not work, change the treatment
plan according to the clinician's decision.
Arm group label:
TCbHP
Arm group label:
ddEC-THP
Summary:
The study is being conducted to assess the efficacy and safety of
anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP
neoadjuvant therapy for HER2-positive breast cancer
Detailed description:
A Multicenter, Randomized, Open, Phase III，The study is being conducted to assess the
efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an
anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer,Subjects
will be treated until disease progression, toxicity is intolerable, informed consent is
withdrawn, and investigators determine that medication must be discontinued. Drug
efficacy and safety data will be collected.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 ~70 years old, female;
2. Histologically confirmed patients with previously untreated stage Ⅱ-Ⅲ HER2-positive
breast cancer;
3. HER-2 positive breast cancer, defined as immunohistochemical (IHC) detection of 3+
or in situ hybridization (FISH) results of HER2 gene amplification;
4. There is at least one measurable objective lesion according to RECIST 1.1 criteria;
5. ECOG Physical fitness score is 0-2;
6. Left ventricular ejection fraction LVEF≥50%;
7. Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin
≥90g/L;
8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal
value; AST and ALT≤2.5 times the upper limit of normal, or ≤5 times the upper limit
of normal in the presence of liver metastasis; Total bilirubin ≤1.5 times the upper
limit of normal, or ≤2.5 times the upper limit of normal in patients with Gilbert's
syndrome, creatinine clearance greater than 30 mL/min;
9. For female patients who are not menopausal or have not been surgically sterilized:
consent to abstinence or use an effective contraceptive method during treatment and
for at least 7 months after the last dose in the study treatment
10. The patient has good compliance with the planned treatment, can understand the
research process of the study and sign the written informed consent.
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer patients;
2. Patients with inflammatory breast cancer
3. Serious heart disease or discomfort, including but not limited to:
- History of heart failure or systolic dysfunction (LVEF < 50%)
- High-risk uncontrolled arrhythmias such as atrial tachycardia, resting heart
rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular
tachycardia) or higher-grade atrioventricular block (i.e., Mobitz II
second-degree atrioventricular block or third-degree atrioventricular block)
Angina pectoris that requires antiangina medication
- valvular heart disease of clinical significance
- ECG showed transmural myocardial infarction
- Poor hypertension control (systolic blood pressure > 180 mmHg and/or diastolic
blood pressure > 100 mmHg)
4. Known allergic history of drug components of this protocol; A history of
immunodeficiency, including HIV positive, or other acquired, congenital
immunodeficiency diseases, or a history of organ transplantation;
5. Patients with severe systemic infection or accompanied by other serious diseases;
6. Have developed other malignant tumors within the previous 5 years, except for cured
cervical carcinoma in situ and non-melanoma skin cancer;
7. Pregnant and lactating women, fertile women who tested positive for baseline
pregnancy tests, or patients of childbearing age who were unwilling to take
effective contraceptive measures during the entire trial period and within 6 months
after the last study;
8. Patients who participated in other studies within 30 days prior to the first dose of
the investigational drug;
9. Patients deemed unsuitable for this study by the investigator.
10. The patient has good compliance with the planned treatment, can understand the
research process of the study and sign the written informed consent.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongsheng Tong, MD
Phone:
+8618622221181
Email:
18622221181@163.com
Start date:
October 8, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871918
