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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Docetaxel; Drug: Epirubicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193050

SCRI BRE 51

Details and patient eligibility

About

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.

Full description

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Epirubicin

Drug: Docetaxel

Drug: Gemcitabine