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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Gemcitabine
Drug: Epirubicin
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Pathologic Complete Response (pCR) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: November 2001
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Gemcitabine
Other Name: Gemzar
Drug: Epirubicin
Epirubicin
Other Name: Ellence
Drug: Docetaxel
Docetaxel
Other Name: Taxotere

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193050

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

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193050     History of Changes
Other Study ID Numbers: SCRI BRE 51
Study First Received: September 12, 2005
Results First Received: August 22, 2012
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 25, 2014