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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Capecitabine Trastuzumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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:

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) ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Percentage of Participants With Local Recurrence [ Time Frame: 30 - 1102 days ] [ Designated as safety issue: No ]
Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.
Participants With Disease-Free Survival [ Time Frame: 30 - 1102 days ] [ Designated as safety issue: No ]
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.
Participants With Overall Survival [ Time Frame: 22 - 1191 days ] [ Designated as safety issue: No ]
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.

Enrollment:	157
Study Start Date:	August 2005
Study Completion Date:	July 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127933

Show 38 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00127933 History of Changes
Other Study ID Numbers:	ML18530
Study First Received:	August 5, 2005
Results First Received:	March 30, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Capecitabine
Fluorouracil

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013