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Completed

NCT Number: NCT02005783

Study of Danggui Buxue Decoction in Preventing Neutropenia

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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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBD

Drug

DBD:one dose of medicine twice per day, orally

Other names: Danggui Buxue Decoction

Epirubicin

Drug

Epirubicin:90mg/m2, d1, q3w*4

Cyclophosphamide

Drug

Cyclophosphamide:600mg/m2, d1, q3w*4

docetaxel

Drug

Docetaxel:75mg/m2, d1, q3w*4

Primary outcomes

  1. incidence of grade 3/4 neutropenia

    Time frame: 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 outcomes

  1. times of grade 3/4 neutropenia per cycle of chemotherapy

    Time frame: 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.

  2. incidence of febrile neutropenia

    Time frame: 3 weeks

    to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

  3. the time to neutropenia recovery

    Time frame: 2 months

    to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: DIPE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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