A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast

The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe, tolerable, and effective in the treatment of patients with infiltrating ductal carcinoma of breast.

Trial Details

NCT ID

NCT02897700

Phase

PHASE1

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
Placebo

Locations (sample)

Ganzhou, Jiangxi, China|25.84664,114.9326
Changchun, Jilin, China|43.88,125.32278
Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

Patients ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast
no severe major organ dysfunction
Patients must have adequate hematopoietic function as evidenced by:
white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transf…

For full eligibility, visit ClinicalTrials.gov.

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