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- Withdrawn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
- Diseases
- Triple-negative breast cancer
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fourth Hospital of Hebei Medical University | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.