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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193050
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gemcitabine Drug: Epirubicin Drug: Docetaxel Phase 2

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2001
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Intervention

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.

Drug: Gemcitabine
Other Name: Gemzar

Drug: Epirubicin
Other Name: Ellence

Drug: Docetaxel
Other Name: Taxotere

Primary Outcome Measures :
  1. Pathologic Complete Response (pCR) [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Time to Treatment Failure (TTF) [ Time Frame: 69 months ]
  2. Overall Survival (OS) [ Time Frame: 48 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193050

Sponsors and Collaborators
SCRI Development Innovations, LLC
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193050     History of Changes
Other Study ID Numbers: SCRI BRE 51
First Posted: September 19, 2005    Key Record Dates
Results First Posted: September 21, 2012
Last Update Posted: September 21, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors