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A Phase I Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of Chemotherapeutic Regiments in Surgical Patients With Infiltrating Ductal Carcinoma of Breast (COC-IDCB)
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.
Details
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 300 |
| Start date | 2013-01 |
| Completion | 2027-12 |
Conditions
- Breast Cancer
Interventions
- Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
- cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
- Placebo
Primary outcomes
- Incidence of treatment-emergent adverse events — 6 months
The case of emergent events caused by treatment is measured by counting the blood cell number and detecting liver and kidney functions. Total blood cell number, alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) \> 20% above upper limit of normal, is considered as not safe. Tolerability is measured by monitoring the first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) (NCI-CTC version 4; or CTCAE v4.0) and/or disruption of chemotherapy because of inacceptable toxicity. Chemotherapeutic efficacy is measured by the remaining tumor size after computed tomography (CT) scanning and comparing it with the original primary tumor size 2-3 weeks after last cycle of chemotherapy. The ratio of post-treatment tumor size to pre-treatment tumor size \< 50% is considered as effective. Otherwise not.
Countries
China