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An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer


Phase 4
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer


Inclusion Criteria:



- women >=18 years of age;

- newly diagnosed;

- infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.

Exclusion Criteria:

- evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;

- previous systemic or local primary treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery

Outcome Description:

Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.

Outcome Time Frame:

at the time of definitive surgery; after four 3-week cycles (3-4 months)

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

ML18530

NCT ID:

NCT00127933

Start Date:

August 2005

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
McLean, Virginia  22101
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Charlotte, North Carolina  
South Burlington, Vermont  
Indianapolis, Indiana  
Charleston, South Carolina