Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)

Hebei Medical University Fourth Hospital1 site in 1 countryMay 10, 2019

InterventionsAlbumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

DrugsAlbumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Overview

Phase: Not Applicable
Intervention: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
Conditions: Triple Negative Breast Cancer
Sponsor: Hebei Medical University Fourth Hospital
Locations: 1
Primary Endpoint: pathologic complete response（pCR）
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 10, 2019

End Date

May 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hebei Medical University Fourth Hospital

Responsible Party

Principal Investigator

Liu Yunjiang

Professor, Director and Vice-president

Hebei Medical University Fourth Hospital

Eligibility 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.

Arms & Interventions

Nab-paclitaxel Based Regimens

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

Paclitaxel Based Regimens

Intervention: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Outcomes

Primary Outcomes

pathologic complete response（pCR）

Time Frame: 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)