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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Gemcitabine

Epirubicin

Docetaxel

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Overall Survival (OS)

Number of participants that are alive at 48th months

Full Information

NCT ID

NCT00193050

First Posted

September 12, 2005

Last Updated

October 4, 2021

Sponsor

SCRI Development Innovations, LLC

Collaborators

Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00193050

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Other Intervention Name(s)

Ellence

Intervention Description

Epirubicin

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel

Primary Outcome Measure Information:

Title

Pathologic Complete Response (pCR)

Description

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 Outcome Measure Information:

Title

Time to Treatment Failure (TTF)

Description

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

Title

Overall Survival (OS)

Description

Number of participants that are alive at 48th months

Time Frame

48 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denise A. Yardley, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

20497920

Citation

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.

Results Reference

result

Links:

URL

http://cigjournals.metapress.com/content/u57304468001h722/

Description

Published article in Clinical Breast Cancer

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial