Study of Danggui Buxue Decoction in Preventing Neutropenia

Phase 2

Completed

• Conditions: Grade 3/4 Neutropenia; Febrile Neutropenia
• Interventions: Drug: DBD; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

• Registration Number: NCT02005783
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-09
• Status Verified: 2015-05
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBD arm	DBD	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
DBD arm	Epirubicin	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
DBD arm	Cyclophosphamide	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	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
DBD arm	Docetaxel	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	Epirubicin	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
EC/TC	Cyclophosphamide	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

Primary Outcome Measures

Name	Time	Method
incidence of grade 3/4 neutropenia	3 weeks	To compare the incidence of grade 3/4 neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

Secondary Outcome Measures

Name	Time	Method
times of grade 3/4 neutropenia per cycle of chemotherapy	3 weeks	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.
incidence of febrile neutropenia	3 weeks	to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
the time to neutropenia recovery	2 months	to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China