Testing chemotherapy options for breast cancer patients undergoing surgery
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
This study is testing different chemotherapy drugs to see how well they help women with a common type of breast cancer before or after surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, Methotrexate, Cyclophosphamide, Doxorubicin, radiation |
| Locations | 3 sites (Ganzhou, Jiangxi and 2 other locations) |
| Trial ID | NCT02897700 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed infiltrating ductal carcinoma of the breast and adequate organ function.
Not a fit: Patients with severe organ dysfunction or those who have received prior cancer-associated chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective chemotherapy options that improve outcomes for women with infiltrating ductal carcinoma of the breast.
How similar studies have performed: Other studies have shown success with similar chemotherapy regimens in treating breast cancer, indicating a potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ganzhou, Jiangxi and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.