Completed

Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

What is being tested

Gemcitabine

+ Epirubicin

+ Docetaxel

Drug

Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 2001

See protocol details

Summary

Principal SponsorSCRI Development Innovations, LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2001

Actual date on which the first participant was enrolled.

Upon determination of eligibility, all patients will be receive: Gemcitabine + Epirubicin + Docetaxel

Official TitlePhase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

NCT00193050

Principal SponsorSCRI Development Innovations, LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Adenocarcinoma of the breast confirmed by biopsy * Female Patients \>18 years of age * Normal cardiac function * Ability to perform activities of daily living with minimal assistance * Chemotherapy naïve or have received prior chemotherapy \> 5 years ago * Adequate bone marrow, liver and kidney function * Be informed of the investigational nature of this study * Sign an informed consent form * Sentinel lymph node and/or axillary dissection prior to enrollment Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Life expectancy of \< than 6 months * History of significant heart disease * Prior chemotherapy or hormonal therapy * Concurrent Trastuzumab therapy * History of significant psychiatric disorders * History of active uncontrolled infection Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers