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

NCT04067102 | Withdrawn

• 1 other identifier: TNBC-NEO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• pathologic complete response（pCR）

  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)

  6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  3 months

• Disease-free survival（DFS）

  5 years

• Overall survival（OS）

  5 years

• adverse events（AEs）

  until 28 days after the last study drug administration

Study Arms (2)

Nab-paclitaxel Based Regimens

EXPERIMENTAL

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

Paclitaxel Based Regimens

ACTIVE COMPARATOR

Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Interventions

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

Nab-paclitaxel Based Regimens

paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide 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

Paclitaxel Based Regimens

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Yunjiang Liu, MD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director and Vice-president

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 26, 2019
• Study Start: May 10, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2026
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)