A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast (NCT02897700) | Clinical Trial Compass
RecruitingPhase 1
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
China300 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion 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 transfusion dependent
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal
* Individuals of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1.
* World Health Organization (WHO) performance status of 0 or 1
* No prior or concurrent cancer-associated chemotherapy, no initiation of new hormonal therapy
* Hormone receptor (estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2)) status not specified
* Menopausal status not specified
* Patients or their legal representatives must be willing and able to provide written informed consent
* A Clinical Stage ≥ I subtype A (IA) (T1a, N0, M0) of Beast Cancer but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer-PrimaryTumor, Regional Nodes and Metastasis (TNM) staging system) as determined by a preoperative evaluation that included a chest computed tomography (CT) scan and/or X-ray mammography.
Exclusion Criteria:
* Age \< 18
* Severe major organ dysfunction
* WHO performa…
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: 6 months
Trial details
NCT IDNCT02897700
SponsorShanghai Jiao Tong University School of Medicine