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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Epirubicin; Drug: Albumin-bound Paclitaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Jacksonville, Florida, United States, 32256
      • Integrated Community Oncology Network
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Cancer Care and Research
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Consultants in Blood Disorders and Cancer
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Hematology Oncology Life Center
  • Maine
    • Portland, Maine, United States, 04101
      • Mercy Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology and Hematology Associates
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: Gemzar; Systemic therapy; Drug: Epirubicin; Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles; Other Names: Systemic therapy; Ellence; Drug: Albumin-bound Paclitaxel; ABI-007 175 mg/m2 D1 q 14 days x 6 cycles; Other Names: ABI-007; Abraxane; Systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rates of Breast Preservation	Number of patients who underwent breast conservation after neo adjuvant chemotherapy	18 months

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Eli Lilly and Company; Celgene Corporation
• Investigators: Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Gemcitabine; Breast Cancer; Gemzar; Epirubicin; Abraxane; Locally Advanced Breast Cancer; Inflammatory Breast Cancer; nab Paclitaxel
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Inflammatory Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Gemcitabine; Paclitaxel; Epirubicin; Albumin-Bound Paclitaxel
• Other Study ID Numbers: SCRI BRE 73