A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: China-Japan Union Hospital, Jilin University; Ganzhou City People's Hospital; Shanghai 10th People's Hospital
• Treatments: Antineoplastic Agents; Cyclophosphamide; Doxorubicin; Epirubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate

Criteria

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.