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

Phase 2CompletedNCT00193206

SCRI Development Innovations, LLC123 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Breast Cancer

Interventions

GemcitabineDRUG

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

EpirubicinDRUG

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

Albumin-bound PaclitaxelDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Florida Cancer Specialists

Fort Myers, Florida, United States

Integrated Community Oncology Network

Jacksonville, Florida, United States

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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 frame: 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)

Time frame: 36 months

Rates of Breast Preservation

Number of patients who underwent breast conservation after neo adjuvant chemotherapy

Time frame: 18 months

Data from ClinicalTrials.gov

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