Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
1 other identifier
interventional
123
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Sep 2005
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
November 30, 2012
CompletedNovember 23, 2021
November 1, 2021
3.1 years
September 12, 2005
August 22, 2012
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
18 months
Secondary Outcomes (3)
Clinical Response Rates
18 months
Time to Disease Progression
36 months
Rates of Breast Preservation
18 months
Study Arms (1)
Intervention
EXPERIMENTALPatients 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.
Interventions
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Eligibility Criteria
You may qualify if:
- To be included in this study, you must meet the following criteria:
- Locally advanced/inflammatory adenocarcinoma of the breast
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Eli Lilly and Companycollaborator
- Celgene Corporationcollaborator
Study Sites (13)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Mercy Hospital
Portland, Maine, 04101, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Related Publications (1)
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.
PMID: 20670921BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Denise A. Yardley, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
September 1, 2005
Primary Completion
October 1, 2008
Study Completion
May 1, 2009
Last Updated
November 23, 2021
Results First Posted
November 30, 2012
Record last verified: 2021-11