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This is a randomized, multicenter, open, controlled Post-Marketing Study. 272 early stage female breast cancer patients who were histopathology confirmed with adjuvant chemotherapy indications were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by trastuzumab,age,baseline cardiac risk factors.
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of pegylated liposomal doxorubicin(PLD) 35 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; once every 21days, for 4 cycles. Sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21 days, for 4 cycles.
Group B: intravenous infusion of doxorubicin 60 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21days, for 4 cycles. The primary endpoint is cardiotoxity,the secondary endpoint is 5-year disease-free survival (DFS), 5-year overall survival (OS), and safety: hematology and non hematological toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLD plus CTX sequential docetaxel or PTX | Experimental | pegylated liposomal doxorubicin 35 mg/m2,i.v.,d1, plus cyclophosphamide(CTX) 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel(PTX) 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles. |
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| DOX plus CTX sequential docetaxel or PTX | Active Comparator | doxorubicin(DOX) 60 mg/m2,i.v.,d1, plus cyclophosphamide 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLD | Drug | pegylated liposomal doxorubicin is 35 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiotoxity | Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF | 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year DFS | 5-year disease-free survival rate | 5 years |
| 5-year OS | 5-year overall survival rate | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiandong nie, doctor | Contact | 0311-66575708 | niejd@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| zhimin shao, doctor | Fudan University affiliated cancer hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University affiliated cancer hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40504550 | Derived | Tang L, He M, Geng C, Fan Z, Ling R, Qiao G, Cai L, Luo T, Jin F, Wang H, Zhang A, Zhang H, Zeng X, Wang X, Jiang M, Wang Z, Shao Z. Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial. Oncologist. 2025 Jun 4;30(6):oyaf101. doi: 10.1093/oncolo/oyaf101. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C041277 | 1-dodecylpyridoxal |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| CTX | Drug | cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel. |
|
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| Docetaxel | Drug | docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle. |
|
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| Paclitaxel | Drug | paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle. |
|
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| Doxorubicin | Drug | doxorubicin is 60 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide. |
|
|
| Adverse events (AE) | Incidence and Severity of adverse events according to the CTC AE V4.03 | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |