A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
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.
Infiltrating ductal carcinoma (IDC) of breast, or sometimes called invasive ductal carcinoma
 of breast, is the most common type of breast malignancy. About 80% of all breast cancers are
 IDCs.

 Once found, IDC usually has already broken through the wall of the milk duct and begun to
 invade the tissues of the breast. Over time, IDC can spread to the lymph nodes and possibly
 to other areas of the body with high frequency.

 According to the statistics of American Cancer Society, more than 180,000 women in the United
 States are diagnosed with IDC each year. Although IDC can affect women at any age, it is more
 common as they grow older. Further, approximately two-thirds of women are 55 or older when
 they are diagnosed with such this symptom.

 The treatments for invasive ductal carcinoma fall into two broad categories. First, local
 treatments for IDC, including surgery and radiation, which treat the primary tumor and
 surrounding areas such as the chest and lymph nodes. Second, systemic treatments for IDC,
 including chemotherapy, hormone therapy and targeted therapy, which are supposed to deliver
 cytotoxicity throughout the body to eliminate any cancer cells that have left the primary
 site and to help minimize the risk of recurrent disease.

 PURPOSE: This randomized phase I trial is to determine the safety, tolerability and efficacy
 of single or concurrent administration of cyclophosphamide, doxorubicin, epirubicin,
 fluorouracil and methotrexate (CDEFM) to women undergoing surgery for infiltrating ductal
 carcinoma in situ breast cancer.

 RATIONALE: This is a randomized, controlled, open-labeled and multicenter, pilot study.
 Patients are randomized to 1 of 2 treatment arms (arms A or B). Patients accrued as control
 participants are assigned to arm C. to implement the study, the investigators will collect
 surgical samples of the primary tumor and periphery blood from breast cancer patients to
 assess the effects of chemotherapeutic regimens and correlation with post-therapy survival in
 the patient cohorts. Besides the five-year disease-free survival, overall survival and
 five-year metastasis-free survival post treatment, the investigators also analyze and
 evaluate the anticancer agent-induced tumor stroma damage extent, which may provide further
 evidence to confirm the treatment efficacy and appraise the potential influence of a damaged
 tumor microenvironment on disease progression or regression in clinical settings.
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.