Study of Danggui Buxue Decoction in Preventing Neutropenia (DIPE)

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Febrile Neutropenia; Grade 3/4 Neutropenia

Treatments: Drug: Docetaxel; Drug: Epirubicin; Drug: DBD; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02005783

RJBC1302

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

DBD arm

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Drug: DBD

Drug: Epirubicin

Drug: Cyclophosphamide

EC/TC

Other group

Description:

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

Treatment:

Drug: Docetaxel

Drug: Epirubicin

Drug: Cyclophosphamide