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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Docetaxel; Drug: Epirubicin

Detailed Description

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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; Gemcitabine; Other Names: Gemzar; Drug: Docetaxel; Docetaxel; Other Names: Taxotere; Drug: Epirubicin; Epirubicin; Other Names: Ellence

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Eli Lilly and Company; Aventis Pharmaceuticals; Pharmacia and Upjohn
• Investigators: Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC

Publications and helpful links

General Publications

• Yardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029.

Helpful Links

• Published article in Clinical Breast Cancer

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Inflammatory Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Gemcitabine; Docetaxel; Epirubicin
• Other Study ID Numbers: SCRI BRE 51