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Completed

NCT Number: NCT00193206

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Florida Cancer Specialists, Fort Myers, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles

Other names: Systemic therapy, Gemzar

Epirubicin

Drug

Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles

Other names: Systemic therapy, Ellence

Albumin-bound paclitaxel

Drug

ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Other names: Systemic therapy, ABI-007, Abraxane

Primary outcomes

  1. Pathologic Complete Response

    Time frame: 18 months

    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 outcomes

  1. Clinical Response Rates

    Time frame: 18 months

    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)

  2. Time to Disease Progression

    Time frame: 36 months

    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)

  3. Rates of Breast Preservation

    Time frame: 18 months

    Number of patients who underwent breast conservation after neo adjuvant chemotherapy

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Celgene Corporation
  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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