Status:
WITHDRAWN
Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment o...
Eligibility Criteria
Inclusion
- Female, aged ≥ 18 yrs and ≤70 yrs；
- Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
- The expression of ER\<10%，PR \<10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
- ECOG performance status 0-1；
- LVEF≥55%；
- Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
- Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
- The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.
Exclusion
- Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
- New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
- Patients with severe systemic infections or other serious illnesses；
- Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
- Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
- Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
- Participated in other experimental studies within 30 days before the first dose of study drug administration
- Researchers judged patients who were unsuitable for this study.
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04067102
Start Date
May 10 2019
End Date
May 1 2026
Last Update
July 9 2021
Active Locations (1)
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1
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011