Overview

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.