MedTrace Logo

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

NCT02897700 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • China-Japan Union Hospital, Jilin University

    collaborator OTHER

  • Ganzhou City People's Hospital

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Yu Sun, Ph.D · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897700 on ClinicalTrials.gov