A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast — COC-IDCB  

Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Infiltrating ductal carcinoma (IDC) of breast, or sometimes called invasive ductal carcinoma of breast, is the most common type of breast malignancy. About 80% of all breast cancers are IDCs.

Once found, IDC usually has already broken through the wall of the milk duct and begun to invade the tissues of the breast. Over time, IDC can spread to the lymph nodes and possibly to other areas of the body with high frequency.

According to the statistics of American Cancer Society, more than 180,000 women in the United States are diagnosed with IDC each year. Although IDC can affect women at any age, it is more common as they grow older. Further, approximately two-thirds of women are 55 or older when they are diagnosed with such this symptom.

The treatments for invasive ductal carcinoma fall into two broad categories. First, local treatments for IDC, including surgery and radiation, which treat the primary tumor and surrounding areas such as the chest and lymph nodes. Second, systemic treatments for IDC, including chemotherapy, hormone therapy and targeted therapy, which are supposed to deliver cytotoxicity throughout the body to eliminate any cancer cells that have left the primary site and to help minimize the risk of recurrent disease.

PURPOSE: This randomized phase I trial is to determine the safety, tolerability and efficacy of single or concurrent administration of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) to women undergoing surgery for infiltrating ductal carcinoma in situ breast cancer.

RATIONALE: This is a randomized, controlled, open-labeled and multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms A or B). Patients accrued as control participants are assigned to arm C. to implement the study, the investigators will collect surgical samples of the primary tumor and periphery blood from breast cancer patients to assess the effects of chemotherapeutic regimens and correlation with post-therapy survival in the patient cohorts. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also analyze and evaluate the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to confirm the treatment efficacy and appraise the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast

• NCT number: NCT02897700
• Study type: Interventional
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yu Sun, Ph.D
• Phone: 86-21-54923302
• Email: sunyu@sibs.ac.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2013
• Completion date: December 2027