Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

Hebei Medical University

Status

Withdrawn

Conditions

Triple Negative Breast Cancer

Treatments

Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04067102

TNBC-NEO

Details and patient eligibility

About

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 of triple negative breast cancer.

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.