Clinical trial · Interventional
To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study
NCT05656079CI-TRIAL-00062765easy laughunknownN/AClinicalTrials.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)
To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pegylated liposomal doxorubicin;cyclophosphamide;trastuzumab;pertuzumab ;docetaxel
- description
- Pegylated liposomal doxorubicin 35 mg/m2, i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1 +Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1 ; q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+ Pertuzumab 420 mg, i.v. d1+Trastuzumab 6 mg/kg, i.v. d1; q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.
- interventionNames
- Drug: Pegylated liposomal doxorubicin
- Drug: Cyclophosphamid
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Epirubicin;cyclophosphamide f;docetaxel;trastuzumab;pertuzumab
- description
- Epirubicin 90 mg/m2 , i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1; q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1; q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-70 years old, Female; 2. Subjects with histopathologically confirmed invasive breast cancer; 3. HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity); 4. No distant metastasis; 5. Lymph node positive or negative, primary tumour≥2cm; 6. Lymph node negative,primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (\<10%) and PR negative (\<20%); 3) Age\<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus; 7. Surgery was completed and chemotherapy was started within 8 weeks after surgery; 8. Before and after chemotherapy LVEF≥55%; 9. ECOG performance status of 0-1; 10. Signed the informed consent. Exclusion Criteria: 1. Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients; 2. Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma); 3. For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment); 4. Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal; 5. Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease; 6. Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg; 7. NYHA cardiac insufficiency grading ≥ Ⅲ grade; 8. Severe, uncontrollable systemic disease; 9. Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment; 10. Subjects who participated in other clinical trials at the same time; 11. Subjects determined by the investigator to be inappropriate to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.