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

NCT ID: NCT04067102

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2026-05-31

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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel Based Regimens

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Paclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment

Paclitaxel Based Regimens

Group Type: ACTIVE_COMPARATOR

paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Intervention Type: DRUG

Paclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher

Interventions

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

Paclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment

Intervention Type: DRUG

paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Paclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Yunjiang

Professor, Director and Vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunjiang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

TNBC-NEO

Identifier Type: -

Identifier Source: org_study_id