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

NCT ID: NCT00193050

Last Updated: 2021-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine

Epirubicin

Intervention Type DRUG

Epirubicin

Docetaxel

Intervention Type DRUG

Docetaxel

Interventions

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Gemcitabine

Gemcitabine

Intervention Type DRUG

Epirubicin

Epirubicin

Intervention Type DRUG

Docetaxel

Docetaxel

Intervention Type DRUG

Other Intervention Names

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Gemzar Ellence Taxotere

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pharmacia and Upjohn

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denise A. Yardley, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

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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.

Reference Type RESULT
PMID: 20497920 (View on PubMed)

Related Links

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

Published article in Clinical Breast Cancer

Other Identifiers

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SCRI BRE 51

Identifier Type: -

Identifier Source: org_study_id