Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193206
First received: September 12, 2005
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine
Drug: Epirubicin
Drug: Albumin-bound Paclitaxel
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 Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pathologic Complete Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Response Rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rates of Breast Preservation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.
Drug: Gemcitabine
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Other Names:
  • Systemic therapy
  • Gemcitabine
  • Gemzar
Drug: Epirubicin
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Other Names:
  • Systemic therapy
  • Epirubicin
  • Ellence
Drug: Albumin-bound Paclitaxel
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Other Names:
  • Systemic therapy
  • ABI-007
  • Abraxane

Detailed Description:

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

  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:

  • Locally advanced/inflammatory adenocarcinoma of the breast
  • 18 years of age or older
  • Normal heart function
  • Able to perform activities of daily living with minimal assistance
  • No prior chemotherapy for breast cancer
  • Adequate bone marrow, liver and kidney function
  • No evidence or history of significant cardiovascular abnormalities
  • Sentinel node or axillary dissection
  • Sign an informed consent form

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Pregnant or breast feeding
  • History of heart disease with congestive heart failure
  • Heart attack within the previous 6 months
  • Prior chemotherapy or hormone therapy for breast cancer
  • 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: NCT00193206

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Hematology Oncology Life Center
Alexandria, Louisiana, United States, 71301
United States, Maine
Mercy Hospital
Portland, Maine, United States, 04101
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Celgene Corporation
Investigators
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC
  More Information

Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193206     History of Changes
Other Study ID Numbers: SCRI BRE 73
Study First Received: September 12, 2005
Results First Received: August 22, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Locally Advanced Breast Cancer
Inflammatory Breast Cancer
Breast Cancer
Abraxane
nab Paclitaxel
Epirubicin
Gemcitabine
Gemzar

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

ClinicalTrials.gov processed this record on October 23, 2014