Clinical trial · Interventional
Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer
The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial
NCT02903524CI-TRIAL-00023902unknownPhase 4ClinicalTrials.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)
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin Hydrochloride Liposome injection and cyclophosphamide | Drug | — | UNRESOLVED |
| pirarubicin and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy
- interventionNames
- Drug: pirarubicin and cyclophosphamide
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy
- interventionNames
- Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
Primary outcomes (1)
- measure
- pathological complete response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with age between 18 and 70 years. * Newly diagnosed breast cancer, stages IIb-IIIc. * KPS performance status≥70. * Measurable disease according to RECIST version 1.1. * Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%. * Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L). * Adequate hepatic and renal function. * AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal. * Serum creatinine≥44 µmol/L and ≤133 µmol/L. * Written informed consent are acquired. * Not in pregnancy or the pregnancy tests of females is negative. Exclusion Criteria: * Severe heart failure (NYHA grade II or higher). * Active and uncontrolled severe infection. * Have accepted any other anti-tumor drug within 30 days before the first dose or * received radiation treatment. * Other situations that investigators consider as contra-indication for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.