Clinical trial · Interventional
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
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
NCT02897700CI-TRIAL-00076165COC-IDCBrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mono-chemotherapy
- description
- A mono-chemotherapy (a single chemotherapeutic agent out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (or CDEFM) was performed 30\~60 days prior to surgery for patients who had no history of receiving either local or systemic cancer-associated chemotherapy. Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate.
- interventionNames
- Drug: Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
- type
- EXPERIMENTAL
- label
- Combined chemotherapy
- description
- Combined chemotherapy (random combination of two breast cancer chemotherapeutic agents including cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, or CDEFM) was performed 30\~60 days prior to surgery for patients who had no history of receiving either local or systemic chemotherapy for cancer. Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate.
- interventionNames
- Drug: cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 performance status of \>1 * Prior cancer chemotherapy * Stage IV * Patients with symptomatic central nervous system (CNS) metastases from breast cancer * Patients with a history of another invasive malignancy within the last 3 years * History of loss of consciousness or transient ischemic attack within 12 months before study treatment initiation. * Patients who have known active HIV, Hepatitis B, or Hepatitis C infections. * Patients with any other condition which in the opinion of the investigator would preclude participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.