AzTrials
AzTrials

Breast CancerPhase 4NCT00127933

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

A Phase 4 study testing capecitabine [Xeloda], Taxotere and Herceptin (HER2-neu positive patients only) in people with Breast Cancer, run by Hoffmann-La Roche at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
capecitabine [Xeloda], Taxotere and Herceptin (HER2-neu positive patients only)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
38 sitesUnited States
Study dates
Aug 2005to Jul 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women >=18 years of age;
  • newly diagnosed;
  • infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.

Who cannot join

  • evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
  • previous systemic or local primary treatment.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Study site

    Abingdon, Virginia, 24211

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Canton, Ohio, 44718

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28233-3549

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75390-9034

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Georgetown, South Carolina, 29442

  • Study site

    Indianapolis, Indiana, 46227

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Los Angeles, California, 90057

  • Study site

    Melbourne, Florida, 32910

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Miami, Florida, 33136

  • Study site

    Montebello, California, 90640

  • Study site

    Neptune City, New Jersey, 07754

  • Study site

    New York, New York, 10003

  • Study site

    Palm Springs, California, 92262

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pottsville, Pennsylvania, 17901

  • Study site

    Rolla, Missouri, 65401

  • Study site

    San Diego, California, 92123

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Scarborough, Maine, 04074

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Tamarac, Florida, 33321

Other trials in United States

About this study

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

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.

Conditions
Breast Cancer
Being tested
capecitabine [Xeloda], Taxotere, Herceptin (HER2-neu positive patients only)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabine [Xeloda]Drug

    825mg/m2 po bid on days 1-14 of each 3 week cycle

  • TaxotereDrug

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

  • Herceptin (HER2-neu positive patients only)Drug

    4mg/kg iv (loading dose) followed by 2mg/kg iv weekly

  • capecitabine [Xeloda]Drug

    825mg/m2 po bid on days 1-14 of each 3 week cycle

  • TaxotereDrug

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

Study groups in NCT00127933
Study groupRoleWhat they receive
HER2-NEU PositiveExperimentalNot described
Receives: Drug: capecitabine [Xeloda]; Drug: Taxotere; Drug: Herceptin (HER2-neu positive patients only)
HER2-NEU NegativeExperimentalNot described
Receives: Drug: capecitabine [Xeloda]; Drug: Taxotere

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (5)

  1. Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery

    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.

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

  2. Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))

    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.

    Measured: post 2 and 4, 3-week cycles of treatment

  3. Percentage of Participants With Local Recurrence

    Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.

    Measured: 30 - 1102 days

  4. Participants With Disease-Free Survival

    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.

    Measured: 30 - 1102 days

  5. Participants With Overall Survival

    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.

    Measured: 22 - 1191 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionApr 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00127933
Sponsor's protocol ID
ML18530
Status last verified
Jul 2011
First submitted
5 Aug 2005
Last updated
10 Aug 2011

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing capecitabine [Xeloda], Taxotere and Herceptin (HER2-neu positive patients only) in people with Breast Cancer, run by Hoffmann-La Roche at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00127933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in