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To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBD arm | Experimental | Epirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally |
|
| EC/TC | Other | Epirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBD | Drug | DBD:one dose of medicine twice per day, orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of grade 3/4 neutropenia | To compare the incidence of grade 3/4 neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| times of grade 3/4 neutropenia per cycle of chemotherapy | To compare the times of grade 3/4 neutropenia per cycle of chemotherapy between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy. | 3 weeks |
| incidence of febrile neutropenia |
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Inclusion Criteria:
Women aged ≥18 years and < 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3*109/L; Neutrophil ≥ 1.5*109/L; PLT ≥ 100*109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;
Exclusion Criteria:
Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia
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| Name | Affiliation | Role |
|---|---|---|
| Kunwei Shen, Dr | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C477279 | danggui buxue decoction |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| Epirubicin | Drug | Epirubicin:90mg/m2, d1, q3w*4 |
|
| Cyclophosphamide | Drug | Cyclophosphamide:600mg/m2, d1, q3w*4 |
|
| Docetaxel | Drug | Docetaxel:75mg/m2, d1, q3w*4 |
|
to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy. |
| 3 weeks |
| the time to neutropenia recovery | to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy. | 2 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |