Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

Study Overview
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Brief Summary
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Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Detailed Description
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Upon determination of eligibility, all patients will be receive: Gemcitabine + Epirubicin + Docetaxel

Official Title
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Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Epirubicin
* Drug: Docetaxel


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: Adenocarcinoma of the breast confirmed by biopsy Female Patients >18 years of age Normal cardiac function Ability to perform activities of daily living with minimal assistance Chemotherapy naïve or have received prior chemotherapy > 5 years ago Adequate bone marrow, liver and kidney function Be informed of the investigational nature of this study Sign an informed consent form Sentinel lymph node and/or axillary dissection prior to enrollment Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Life expectancy of < than 6 months History of significant heart disease Prior chemotherapy or hormonal therapy Concurrent Trastuzumab therapy History of significant psychiatric disorders 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>In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. | Drug: Gemcitabine<br>* Gemcitabine<br>* Other names: Gemzar;Drug: Epirubicin<br>* Epirubicin<br>* Other names: Ellence;Drug: Docetaxel<br>* Docetaxel<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response (pCR) | For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). 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 |
| --- | --- | --- |
| Time to Treatment Failure (TTF) | Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: disease progression date (RECIST or clinical) death date treatment discontinuation | 69 months | 
| Overall Survival (OS) | Number of participants that are alive at 48th months | 48 months |