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OpenTrials
Completed

NCT Number: NCT00193050

Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Gemcitabine

Other names: Gemzar

Epirubicin

Drug

Epirubicin

Other names: Ellence

docetaxel

Drug

Docetaxel

Other names: Taxotere

Primary outcomes

  1. Pathologic Complete Response (pCR)

    Time frame: 18 Months

    For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Secondary outcomes

  1. Time to Treatment Failure (TTF)

    Time frame: 69 months

    Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates:

    • disease progression date (RECIST or clinical)
    • death date
    • treatment discontinuation

  2. Overall Survival (OS)

    Time frame: 48 months

    Number of participants that are alive at 48th months

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • Eli Lilly and Company
  • Pharmacia and Upjohn

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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