Clinical trial NCT04067102: Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Triple Negative Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: pathologic complete response（pCR）
timeFrame: 6 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 months
measure: Disease-free survival（DFS）
timeFrame: 5 years
measure: Overall survival（OS）
timeFrame: 5 years
measure: adverse events（AEs）
timeFrame: until 28 days after the last study drug administration
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Yunjiang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: