Breast Cancer
Conditions
Interventions
case series:neoadjuvant chemotherapy
Sponsors
The Second Hospital, Cheeloo College of Medicine, Shandong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Newly treated female patients aged >= 18 years old and = 1.5*10^9/L; platelet count (PLT)>=90*10^9/L; hemoglobin (Hb)>= 90g/L; 2) Blood biochemistry: total bilirubin (TBIL) = 55%; 4) 12-lead electrocardiogram: QT interval corrected by Fridericia method (QTcF) < 470msec. (7) For female patients who have not undergone menopause or have not undergone surgical sterilization: during treatment and at least 7 months after the last administration in the study treatment, agree to abstain from sex or use an effective method of contraception. (8) Join the study voluntarily, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) Inflammatory breast cancer; (2) Past anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; (3) At the same time receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; (4) In the 4 weeks before enrollment, the patient has undergone major surgical operations not related to breast cancer, or the patient has not fully recovered from such surgical operations; (5) Severe heart disease or discomfort, including but not limited to the following diseases: --Diagnosed history of heart failure or systolic dysfunction (LVEF 100bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II II Degree atrioventricular block or third degree atrioventricular block); - Angina pectoris that requires anti-angina pectoris medication; -Heart valve disease with clinical significance; --ECG shows transmural myocardial infarction; - Poor hypertension control (systolic blood pressure> 180mmHg and/or diastolic blood pressure> 100mmHg) (6) Those who are known to have a history of allergy to the drug components of this program: have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (7) Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and 7 months after the last study medication; (8) Suffer from serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, or any other conditions that the investigator believes that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heat Shock Proteins 90a; | — |
Countries
China
Contacts
Public ContactZheng Chao
The Second Hospital, Cheeloo College of Medicine, Shandong University
Outcome results
None listed