Clinical trial NCT00193206: Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Official title: Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Locally Advanced Breast Cancer
Inflammatory Breast Cancer
Breast Cancer
Abraxane
nab Paclitaxel
Epirubicin
Gemcitabine
Gemzar
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Celgene Corporation
First posted: 2005-09-19
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: 18 months
Secondary outcomes:
measure: Clinical Response Rates
timeFrame: 18 months
measure: Time to Disease Progression
timeFrame: 36 months
measure: Rates of Breast Preservation
timeFrame: 18 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Cancer Care and Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Alexandria
country: United States
facility: Hematology Oncology Life Center
state: Louisiana
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048.