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

This study has been completed.
Sponsor:
Collaborators:
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193050
First received: September 12, 2005
Last updated: August 22, 2012
Last verified: August 2012

September 12, 2005
August 22, 2012
November 2001
March 2008   (final data collection date for primary outcome measure)
Pathologic Complete Response (pCR) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Assess feasibility and toxicity of the induction administration of the combination of gemcitabine, epirubicin, and docetaxel in patients with locally advanced or inflammatory breast cancer.
Complete list of historical versions of study NCT00193050 on ClinicalTrials.gov Archive Site
  • Time to Treatment Failure (TTF) [ Time Frame: 69 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Objective response rate including pathologic response rates of patients with locally advanced and/or inflammatory breast cancer treated with gemcitabine, epirubicin, and docetaxel
  • To evaluate time to disease response in patients receiving this induction regimen.
  • To evaluate time to disease progression and overall survival.
  • To assess the conversion rate of previously planned mastectomies to breast conservation surgery and unresectable to respectable
  • Evaluate toxicity of this combination.
Not Provided
Not Provided
 
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

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.

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Gemcitabine
    Gemcitabine
    Other Name: Gemzar
  • Drug: Epirubicin
    Epirubicin
    Other Name: Ellence
  • Drug: Docetaxel
    Docetaxel
    Other Name: Taxotere
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.

Interventions:
  • Drug: Gemcitabine
  • Drug: Epirubicin
  • Drug: Docetaxel
Yardley DA, Peacock NW, Dickson NR, White MB, Vázquez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2009
March 2008   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193050
SCRI BRE 51
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
  • Pharmacia and Upjohn
  • Eli Lilly and Company
  • Aventis Pharmaceuticals
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP