Testing chemotherapy options for breast cancer patients undergoing surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the safety, tolerability, and efficacy of various chemotherapeutic agents, including cyclophosphamide, doxorubicin, epirubicin, fluorouracil, and methotrexate, in women diagnosed with infiltrating ductal carcinoma of the breast. Participants will receive either a single agent or a combination of these drugs before or after surgical intervention. The study will assess how well these treatments work in managing the disease and preventing recurrence. It targets a common type of breast cancer that affects a significant number of women annually.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ganzhou City People's Hospital
  Ganzhou, Jiangxi, China Recruiting
• China-Japan Union Hospital, Jilin University
  Changchun, Jilin, China Recruiting
• Shanghai 10th People's Hospital, Tongji University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yu Sun, Ph.D — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Yu Sun, Ph.D
• Email: sunyu@sibs.ac.cn
• Phone: 86-21-54923302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.