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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Epirubicin
Albumin-bound Paclitaxel
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Cancer Specialists
  • Integrated Community Oncology Network
  • Watson Clinic Center for Cancer Care and Research
  • Florida Hospital Cancer Institute
  • Northeast Georgia Medical Center
  • Consultants in Blood Disorders and Cancer
  • Hematology Oncology Life Center
  • Mercy Hospital
  • Oncology Hematology Care
  • Spartanburg Regional Medical Center
  • Chattanooga Oncology and Hematology Associates
  • Tennessee Oncology
  • Peninsula Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Response Rates
Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time to Disease Progression
Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Rates of Breast Preservation
Number of patients who underwent breast conservation after neo adjuvant chemotherapy

Full Information

First Posted
September 12, 2005
Last Updated
November 22, 2021
Sponsor
SCRI Development Innovations, LLC
Collaborators
Eli Lilly and Company, Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00193206
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Eli Lilly and Company, Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Systemic therapy, Gemzar
Intervention Description
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Systemic therapy, Ellence
Intervention Description
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Intervention Type
Drug
Intervention Name(s)
Albumin-bound Paclitaxel
Other Intervention Name(s)
Systemic therapy, ABI-007, Abraxane
Intervention Description
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Primary Outcome Measure Information:
Title
Pathologic Complete Response
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Clinical Response Rates
Description
Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
18 months
Title
Time to Disease Progression
Description
Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
36 months
Title
Rates of Breast Preservation
Description
Number of patients who underwent breast conservation after neo adjuvant chemotherapy
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A. Yardley, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Watson Clinic Center for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Hematology Oncology Life Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20670921
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.
Results Reference
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Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

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