Breast CancerPhase 3NCT00089479

A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

A Phase 3 study testing capecitabine [Xeloda] and Taxotere in people with Breast Cancer, run by Hoffmann-La Roche at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: capecitabine [Xeloda] and Taxotere
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,611 participants
Where: 1 siteUnited States
Study dates: Aug 2002to May 2012
Phase: Phase 3
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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

female patients 18-70 years of age;
adenocarcinoma of the breast;
previous invasive breast cancer if diagnosed >5 years before entering study;
no evidence of metastatic disease.

Who cannot join

history of severe hypersensitivity reaction to Taxotere;
previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Houston, Texas, 77060

Other trials in United States

About this study

Official title: A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions: Breast Cancer
Being tested: capecitabine [Xeloda], Taxotere
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
TaxotereDrug
100mg/m2 iv on day 1 of each 3 week cycle

Study groups in NCT00089479
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: capecitabine [Xeloda]; Drug: Taxotere
2	Active comparator	Not described Receives: Drug: Taxotere

What is being measured

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

Disease Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival [Time to Event]
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Secondary outcomes (8)

Overall Survival [Number of Events]
Number of patients who died/were alive.
Measured: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
Measured: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Measured: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Breast Cancer Free Survival [Time to Event]
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Measured: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Measured: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Timeline

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

Aug 2002May 2012

First posted6 Aug 2004 (estimated)
Study startAug 2002
Primary completionJun 2010
Study completionMay 2012

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,611 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00089479
Sponsor's protocol ID: NO17629
Status last verified: Dec 2012
First submitted: 5 Aug 2004
Last updated: 21 Dec 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
ClinicalTrials.gov ID: NCT00089479
Acronym / sponsor ID: NO17629
Conditions: Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,611 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2002
Primary completion: Jun 2010 (actual)
Study completion: May 2012 (actual)
First posted: 6 Aug 2004 (estimated)
Results: Posted 23 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: capecitabine [Xeloda], Drug: Taxotere
2	Active comparator	Drug: Taxotere

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

female patients 18-70 years of age;
adenocarcinoma of the breast;
previous invasive breast cancer if diagnosed >5 years before entering study;
no evidence of metastatic disease.

Key exclusion criteria (3 listed)

history of severe hypersensitivity reaction to Taxotere;
previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

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	1
Taxotere75mg/m2 iv on day 1 of each 3 week cycle	Drug	1
Taxotere100mg/m2 iv on day 1 of each 3 week cycle	Drug	2

Primary outcome

Disease Free Survival [Number of Events]
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Disease Free Survival [Time to Event]
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

8 secondary outcomes

Overall Survival [Number of Events]
Time frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Time frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Time frame: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Breast Cancer Free Survival [Time to Event]
Time frame: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Results and safety

Results posted to the registry on 23 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AC Then T	1,304	973
AC Then XT	1,307	1,018

Primary outcome: Disease Free Survival [Number of Events]

Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.. Number. Unit: participants

Measure	AC Then T n = 1304	AC Then XT n = 1307
Patients with event	164	140
Patients without events	1140	1167

Population analysed: Intent-to-Treat Population

Primary outcome: Disease Free Survival [Time to Event]

Measure	AC Then T n = 1304	AC Then XT n = 1307
Value	NA (NA to NA)	NA (NA to NA)

Population analysed: Intent-to-Treat Population

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Length of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AC Then T	264 of 1,305 (20.2%)	1,301 of 1,305 (99.7%)	Not reported
AC Then XT	200 of 1,283 (15.6%)	1,283 of 1,283 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

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Not yet recruitingObservational study
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RecruitingPhase 3
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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine [Xeloda] and Taxotere in people with Breast Cancer, run by Hoffmann-La Roche at 1 site 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 4 inclusion and 3 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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Jun 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?

Disease Free Survival [Number of Events] (time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.). The study lists 2 primary outcomes in all. 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 NCT00089479, which also lists 1 linked publication.

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 21 Dec 2012.