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XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00127933
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : August 10, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine [Xeloda] Drug: Taxotere Drug: Herceptin (HER2-neu positive patients only) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: HER2-NEU Positive Drug: capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle

Drug: Taxotere
75mg/m2 iv on day 1 of each 3 week cycle

Drug: Herceptin (HER2-neu positive patients only)
4mg/kg iv (loading dose) followed by 2mg/kg iv weekly

Experimental: HER2-NEU Negative Drug: capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle

Drug: Taxotere
75mg/m2 iv on day 1 of each 3 week cycle




Primary Outcome Measures :
  1. Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery [ Time Frame: at the time of definitive surgery; after four 3-week cycles (3-4 months) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery [ Time Frame: at the time of definitive surgery; after four 3-week cycles (3-4 months) ]
    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.

  2. Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) [ Time Frame: post 2 and 4, 3-week cycles of treatment ]
    The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.

  3. Percentage of Participants With Local Recurrence [ Time Frame: 30 - 1102 days ]
    Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.

  4. Participants With Disease-Free Survival [ Time Frame: 30 - 1102 days ]
    Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.

  5. Participants With Overall Survival [ Time Frame: 22 - 1191 days ]
    Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127933


Locations
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United States, California
Los Angeles, California, United States, 90057
Montebello, California, United States, 90640
Palm Springs, California, United States, 92262
San Diego, California, United States, 92123
United States, Connecticut
Farmington, Connecticut, United States, 06030
United States, Florida
Melbourne, Florida, United States, 32910
Miami, Florida, United States, 33136
Tamarac, Florida, United States, 33321
United States, Georgia
Savannah, Georgia, United States, 31405
United States, Indiana
Indianapolis, Indiana, United States, 46227
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
Alexandria, Louisiana, United States, 71301
United States, Maine
Scarborough, Maine, United States, 04074
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
Jefferson City, Missouri, United States, 65109
Rolla, Missouri, United States, 65401
St Louis, Missouri, United States, 63141
United States, New Jersey
Neptune, New Jersey, United States, 07754
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87108
Albuquerque, New Mexico, United States, 87131-5636
Santa Fe, New Mexico, United States, 87505
United States, New York
New York, New York, United States, 10003
United States, North Carolina
Charlotte, North Carolina, United States, 28233-3549
United States, Ohio
Canton, Ohio, United States, 44718
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Pottsville, Pennsylvania, United States, 17901
United States, South Carolina
Charleston, South Carolina, United States, 29425
Georgetown, South Carolina, United States, 29442
Sumter, South Carolina, United States, 29150
United States, Tennessee
Memphis, Tennessee, United States, 38104
Memphis, Tennessee, United States, 38120
United States, Texas
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75390-9034
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Abingdon, Virginia, United States, 24211
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
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Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00127933    
Other Study ID Numbers: ML18530
First Posted: August 9, 2005    Key Record Dates
Results First Posted: August 10, 2011
Last Update Posted: August 10, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Docetaxel
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Immunological