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

Phase 2CompletedNCT00193050

SCRI Development Innovations, LLC110 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 18 Months

Secondary Outcomes

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

Time frame: 69 months

Overall Survival (OS)

Number of participants that are alive at 48th months

Time frame: 48 months