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

• Status: Withdrawn
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: Female

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 of triple negative breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Epirubicin; Paclitaxel

Criteria

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.