Clinical trial · Interventional
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)
NCT04067102CI-TRIAL-00052614withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients recruited
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide | Drug | — | UNRESOLVED |
| paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel Based Regimens
- interventionNames
- Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel Based Regimens
- interventionNames
- Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
Primary outcomes (1)
- measure
- pathologic complete response（pCR）
- timeFrame
- 6 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.