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

Breast Cancer Clinical Trial

Official title:

Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193206
• Other study ID #: SCRI BRE 73
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: May 2009

Study information

• Verified date: November 2021
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
• Epirubicin
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
• Albumin-bound Paclitaxel
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Locations

Country	Name	City	State
United States	Hematology Oncology Life Center	Alexandria	Louisiana
United States	Chattanooga Oncology and Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology	Nashville	Tennessee
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Mercy Hospital	Portland	Maine
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Celgene Corporation, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	18 months
Secondary	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)	36 months
Secondary	Rates of Breast Preservation	Number of patients who underwent breast conservation after neo adjuvant chemotherapy	18 months