Clinical trial · Interventional
Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
NCT05251766CI-TRIAL-00056693unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm1: epirubicin + cyclophosphamide followed by docetaxel
- description
- Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel
- description
- Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles
- interventionNames
- Drug: Nab paclitaxel
- type
- EXPERIMENTAL
- label
- Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients with age range ≥ 18 years; 2. a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed. 3. HER2 negative breast cancer, tumor \>2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests). 4. Known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]), known Ki67 value; 5. Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1; 6. patients have not previously had breast cancer treatment. 7. During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits; 8. Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable); 9. Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet(PLT)≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase(ALT) ≤ 3 times of the upper limit of normal). Exclusion Criteria: 1. bilateral invasive breast cancer, metastatic disease or other malignant tumors. 2. Surgical axillary staging surgery was performed within 6 months before entering the study; 3. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures; 4. before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out. 5. Patients with central nervous system metastasis or \> grade 1 peripheral neuropathy; 6. Patients with severe myelosuppression at the time of screening; 7. Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening; 8. Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.); 9. Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel; 10. Patients with mental disorders; 11. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration); 12. Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.