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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Epirubicin
* Drug: Albumin-bound Paclitaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles<br>* Other names: Gemzar;Drug: Epirubicin<br>* Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles<br>* Other names: Ellence;Drug: Albumin-bound Paclitaxel<br>* ABI-007 175 mg/m2 D1 q 14 days x 6 cycles<br>* Other names: Abraxane;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar