A Phase 2 interventional study of DBD and Epirubicin in Grade 3/4 Neutropenia and Febrile Neutropenia, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-12-30.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Prevention
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.
155 studies on the registry are indexed under Febrile Neutropenia; 32 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 93 interventional studies indexed under Febrile Neutropenia.
Browse Febrile Neutropenia studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.
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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
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
Drug: DBD · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Docetaxel
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
Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Docetaxel
DBD:one dose of medicine twice per day, orally
Also known as: Danggui Buxue Decoction
Epirubicin:90mg/m2, d1, q3w\*4
Cyclophosphamide:600mg/m2, d1, q3w\*4
Docetaxel:75mg/m2, d1, q3w\*4
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
incidence of febrile neutropenia
to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
Time frame: 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.
Time frame: 2 months
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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