RecruitingPhase 1NCT02897700

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

300 participants

Start Date

Jan 1, 2013

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

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 Criteria10

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.

Interventions

DRUGSingle agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate

Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUGcyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)

Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUGPlacebo

Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.