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This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.
This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.High risk is defined as positive lymph nodes or negative lymph nodes but ki-67 is not less than 50%. We aim to explore whether the addition of carboplatin can improve the disease-free survival of early high-risk triple-negative breast cancer. At the same time, the experimental group's anthracyclines must be given in a dose-dense manner, while anthracyclines in the control group are dose-dense or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional group | Active Comparator | epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks. |
|
| carboplatin group | Experimental | epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin | Drug | 90mg/m2, d1 every 2 or 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 year | |
| distant disease free survival | 3 year | |
| recurrence free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Shao, Professor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41436191 | Derived | Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM. Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial. BMJ. 2025 Dec 23;391:e085457. doi: 10.1136/bmj-2025-085457. |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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1:1 randomized controlled trial
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| CTX |
| Drug |
600mg, d1 every 2 or 3 weeks |
|
| Paclitaxel | Drug | 80mg/m2,d1,d8,d15, every 3 weeks |
|
| ddEpirubicin | Drug | 90mg/m2, d1 every 2 weeks |
|
| ddCTX | Drug | 600mg, d1 every 2 weeks |
|
| Paclitaxel(with carbo) | Drug | 80mg/m2,d1,d8,d15, every 4 weeks |
|
| Carboplatin | Drug | AUC=2,d1,d8,d15, every 4 weeks |
|
| 3 year |
| Disease free survival | 5 year |
| overall survival | 5 year |
| recurrence free survival | 5 year |
| distant disease free survival | 5 year |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |