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NCT02897700

PHASE1

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

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2013-01

Completion Date

2027-12

Last Updated

2024-04-17

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate

Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUG

cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)

Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUG

Placebo

Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.

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.

Locations (3)

Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

China-Japan Union Hospital, Jilin University

Changchun, Jilin, China

Shanghai 10th People's Hospital, Tongji University School of Medicine

Shanghai, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (3)