Study of Danggui Buxue Decoction in Preventing Neutropenia

Study Overview
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Brief Summary
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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.

Official Title
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Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial

Conditions
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Grade 3/4 Neutropenia, Febrile Neutropenia

Intervention / Treatment
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* Drug: DBD
* Drug: Epirubicin
* Drug: Cyclophosphamide
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBD arm<br>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<br>* DBD:one dose of medicine twice per day, orally<br>* Other names: Danggui Buxue Decoction;Drug: Epirubicin<br>* Epirubicin:90mg/m2, d1, q3w*4<br>Drug: Cyclophosphamide<br>* Cyclophosphamide:600mg/m2, d1, q3w*4<br>Drug: Docetaxel<br>* Docetaxel:75mg/m2, d1, q3w*4<br>|
| Other: EC/TC<br>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<br>* Epirubicin:90mg/m2, d1, q3w*4<br>Drug: Cyclophosphamide<br>* Cyclophosphamide:600mg/m2, d1, q3w*4<br>Drug: Docetaxel<br>* Docetaxel:75mg/m2, d1, q3w*4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incidence of grade 3/4 neutropenia, incidence of febrile neutropenia, time to neutropenia recovery, safety