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NCT04067102Withdrawn

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

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)

Source: ClinicalTrials.gov · Last updated 9 Jul 2021

Reason given: No patients recruited

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Interventional
Enrollment
0 (actual)
First submitted
14 Aug 2019
Start date
10 May 2019
Primary completion date
May 2021
Lead sponsor
Hebei Medical University Fourth Hospital
NCT number
NCT04067102

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason;
  • Participated in other experimental studies within 30 days before the first dose of study drug administration

Other illness

  • 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;

Age

  • Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial;

Other

  • Researchers judged patients who were unsuitable for this study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fourth Hospital of Hebei Medical UniversityShijiazhuangChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.