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.
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
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 group | Role | What they receive |
|---|---|---|
| HER2-NEU Positive | Experimental | Not described Receives: Drug: capecitabine [Xeloda]; Drug: Taxotere; Drug: Herceptin (HER2-neu positive patients only) |
| HER2-NEU Negative | Experimental | Not described Receives: Drug: capecitabine [Xeloda]; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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
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
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
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.
- First posted9 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
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
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00127933
- Acronym / sponsor ID
- ML18530
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Aug 2005 (estimated)
- Results
- Posted 10 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-NEU Positive | Experimental | Drug: capecitabine [Xeloda], Drug: Taxotere, Drug: Herceptin (HER2-neu positive patients only) |
| HER2-NEU Negative | Experimental | Drug: capecitabine [Xeloda], Drug: Taxotere |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women >=18 years of age;
- newly diagnosed;
- infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.
Key exclusion criteria (2 listed)
- evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
- previous systemic or local primary treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine [Xeloda]825mg/m2 po bid on days 1-14 of each 3 week cycle | Drug | HER2-NEU Positive |
| Taxotere75mg/m2 iv on day 1 of each 3 week cycle | Drug | HER2-NEU Positive |
| Herceptin (HER2-neu positive patients only)4mg/kg iv (loading dose) followed by 2mg/kg iv weekly | Drug | HER2-NEU Positive |
| capecitabine [Xeloda]825mg/m2 po bid on days 1-14 of each 3 week cycle | Drug | HER2-NEU Negative |
| Taxotere75mg/m2 iv on day 1 of each 3 week cycle | Drug | HER2-NEU Negative |
Primary outcome
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.
5 secondary outcomes
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)
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
Percentage of Participants With Local Recurrence
Time frame: 30 - 1102 days
Participants With Disease-Free Survival
Time frame: 30 - 1102 days
Participants With Overall Survival
Time frame: 22 - 1191 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
38 sites in 1 country: see every site and its status.
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?
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.