Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT04067102
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- 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 of triple negative breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nab-paclitaxel Based Regimens Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide - Paclitaxel Based Regimens paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide -
- Primary Outcome Measures
Name Time Method pathologic complete response（pCR） 6 months pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)
- Secondary Outcome Measures
Name Time Method Disease-free survival（DFS） 5 years Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.
adverse events（AEs） until 28 days after the last study drug administration AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
Objective Response Rate (ORR) 3 months Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Overall survival（OS） 5 years Overall survival is defined as the length of time from random assignment to death or to last contact.
Trial Locations
- Locations (1)
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China