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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemcitabine
Epirubicin
Docetaxel
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Pathologic Complete Response (pCR)
    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 Outcome Measures

    Time to Treatment Failure (TTF)
    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
    Overall Survival (OS)
    Number of participants that are alive at 48th months

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    October 4, 2021
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193050
    Brief Title
    Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
    Official Title
    Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Upon determination of eligibility, all patients will be receive: Gemcitabine + Epirubicin + Docetaxel

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Other Intervention Name(s)
    Gemzar
    Intervention Description
    Gemcitabine
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin
    Other Intervention Name(s)
    Ellence
    Intervention Description
    Epirubicin
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Other Intervention Name(s)
    Taxotere
    Intervention Description
    Docetaxel
    Primary Outcome Measure Information:
    Title
    Pathologic Complete Response (pCR)
    Description
    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.
    Time Frame
    18 Months
    Secondary Outcome Measure Information:
    Title
    Time to Treatment Failure (TTF)
    Description
    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
    Time Frame
    69 months
    Title
    Overall Survival (OS)
    Description
    Number of participants that are alive at 48th months
    Time Frame
    48 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Denise A. Yardley, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20497920
    Citation
    Yardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029.
    Results Reference
    result
    Links:
    URL
    http://cigjournals.metapress.com/content/u57304468001h722/
    Description
    Published article in Clinical Breast Cancer

    Learn more about this trial

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

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