Clinical trial · Observational
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
NCT05731258CI-TRIAL-00064004recruitingClinicalTrials.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)
The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.
Conditions
Conditions (5)
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 |
| Efficacy | — | UNRESOLVED | — |
| Liposomal Doxorubicin | — | UNRESOLVED | — |
| Postoperative Adjuvant Treatment | — | UNRESOLVED | — |
| Safety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal doxorubicin containing regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cardiac safety
- timeFrame
- 10 years
- description
- Cardiac ejection fraction
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, aged 18-75 years; 2. Primary breast cancer diagnosed histopathologically; 3. Adjuvant chemotherapy regimens include liposomal doxorubicin; 4. ECoG PS score: 0-1 points; 5. Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Estimated survival ≥ 6 months; 7. Major organ function is normal, i.e. meets the following criteria: ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L;② Platelets ≥ 100 × 10 9 /L;③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5 × ULN;⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN;⑦ Total bilirubin ≤ 1.5 × ULN;⑧ Serum creatinine ≤ 1.5 × ULN; 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up. Exclusion Criteria: 1. Pregnant, lactating patients; 2. Breast cancer has been found to have distant metastasis; 3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders; 4. Those with severe infection or active peptic ulcer requiring treatment; 5. Allergic to chemotherapy drugs; 6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix; 7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes; 8. Patients who are participating in other clinical trials or within a month.
References
Publications (0)
Data not yet available
No reference posted for this study.