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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193050
• Other study ID #: SCRI BRE 51
• Status: Completed
• Phase: Phase 2
• Start date: November 2001
• Est. completion date: March 2009

Study information

• Verified date: October 2021
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine
• Epirubicin
Epirubicin
• Docetaxel
Docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Eli Lilly and Company, Pharmacia and Upjohn

References & Publications (1)

Yardley DA, Peacock NW, Dickson NR, White MB, Vázquez 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 inflamma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival (OS)	Number of participants that are alive at 48th months	48 months

External Links

•   Published article in Clinical Breast Cancer