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

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Gemcitabine
Drug: Epirubicin
Drug: Docetaxel

Registration Number: NCT00193050

Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary: 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: Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 110

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Epirubicin	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.
Intervention	Docetaxel	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.
Intervention	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR)	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). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	48 months	Number of participants that are alive at 48th months
Time to Treatment Failure (TTF)	69 months	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