NCT02897700 A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
| NCT ID | NCT02897700 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2013-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 300 participants in total. It began in 2013-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Yu Sun, Ph.D
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT02897700 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02897700 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02897700 currently recruiting?
Yes, NCT02897700 is actively recruiting participants. Contact the research team at sunyu@sibs.ac.cn for enrollment information.
Where is the NCT02897700 trial being conducted?
This trial is being conducted at Ganzhou, China, Changchun, China, Shanghai, China.
Who is sponsoring the NCT02897700 clinical trial?
NCT02897700 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Yu Sun, Ph.D at Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 300 participants.
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