Trial · NCT00089479

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

NCT00089479, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer. Trials, record NCT00089479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089479

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
NCT number: NCT00089479
Status: Completed
Phases: Phase 3
Enrollment: 2,611 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: capecitabine [Xeloda], Taxotere, Taxotere
First posted: 2004-08-06
Last updated: 2012-12-21
Results first posted: 2011-06-23

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Free Survival [Number of Events]	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.
Primary	Disease Free Survival [Time to Event]	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.
Secondary	Overall Survival [Number of Events]	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.	Number of patients who died/were alive.
Secondary	Overall Survival [Time to Event]	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 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.
Secondary	Breast Cancer Free Survival [Number of Events]	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 .	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.
Secondary	Breast Cancer Free Survival [Time to Event]	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.	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.
Secondary	Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]	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, new primary breast cancer, or death due to any cause.
Secondary	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, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	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.
Secondary	Disease Free Survival Including Any New Cancer as Event [Number of Events]	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, any new cancer, or death due to any cause.
Secondary	Disease Free Survival Including Any New Cancer as Event [Time to Event]	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.	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.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Free Survival [Number of Events]	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.	Intent-to-Treat Population	participants	NUMBER
SECONDARY	Overall Survival [Number of Events]	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.	Intent-to-Treat Population	participants	NUMBER
PRIMARY	Disease Free Survival [Time to Event]	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.	Intent-to-Treat Population	months	MEDIAN
SECONDARY	Overall Survival [Time to Event]	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.	Intent-to-Treat Population	months	MEDIAN
SECONDARY	Breast Cancer Free Survival [Number of Events]	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 .	Intent-to-Treat Population	participants	NUMBER
SECONDARY	Breast Cancer Free Survival [Time to Event]	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.	Intent-to-Treat Population	months	MEDIAN
SECONDARY	Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]	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.	Intent-to-Treat Population	participants	NUMBER
SECONDARY	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, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Intent-to-Treat Population	months	MEDIAN
SECONDARY	Disease Free Survival Including Any New Cancer as Event [Number of Events]	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.	Intent-to-Treat Population	participants	NUMBER
SECONDARY	Disease Free Survival Including Any New Cancer as Event [Time to Event]	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.	Intent-to-Treat Population	months	MEDIAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease Free Survival [Number of Events]	AC Then T	Patients with event	164		participants
Disease Free Survival [Number of Events]	AC Then XT	Patients with event	140		participants
Disease Free Survival [Number of Events]	AC Then T	Patients without events	1140		participants
Disease Free Survival [Number of Events]	AC Then XT	Patients without events	1167		participants
Overall Survival [Number of Events]	AC Then T	Patients with event	108		participants
Overall Survival [Number of Events]	AC Then XT	Patients with event	75		participants
Overall Survival [Number of Events]	AC Then T	Patients without events	1196		participants
Overall Survival [Number of Events]	AC Then XT	Patients without events	1232		participants
Disease Free Survival [Time to Event]	AC Then T		NA	95% Confidence Interval NA to NA	months
Disease Free Survival [Time to Event]	AC Then XT		NA	95% Confidence Interval NA to NA	months

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AC Then T	1,304
Overall Study	STARTED	AC Then XT	1,307
Overall Study	Received Treatment	AC Then T	1,305
Overall Study	Received Treatment	AC Then XT	1,283
Overall Study	COMPLETED	AC Then T	973
Overall Study	COMPLETED	AC Then XT	1,018
Overall Study	NOT COMPLETED	AC Then T	331
Overall Study	NOT COMPLETED	AC Then XT	289

Source ClinicalTrials.gov

Adverse events492

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	NAUSEA	Gastrointestinal disorders	AC Then T	1,125	1,305
other	NAUSEA	Gastrointestinal disorders	AC Then XT	1,118	1,283
other	STOMATITIS ALL	Gastrointestinal disorders	AC Then T	848	1,305
other	STOMATITIS ALL	Gastrointestinal disorders	AC Then XT	980	1,283
other	DIARRHOEA	Gastrointestinal disorders	AC Then T	581	1,305
other	DIARRHOEA	Gastrointestinal disorders	AC Then XT	759	1,283
other	VOMITING	Gastrointestinal disorders	AC Then T	618	1,305
other	VOMITING	Gastrointestinal disorders	AC Then XT	591	1,283
other	CONSTIPATION	Gastrointestinal disorders	AC Then T	552	1,305
other	CONSTIPATION	Gastrointestinal disorders	AC Then XT	596	1,283

1 to 10 of 492Source ClinicalTrials.gov

See all 492 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AC Then T
Total, all-cause mortality	AC Then XT
Total, other adverse events	AC Then T	1,301	1,305
Total, other adverse events	AC Then XT	1,283	1,283
Total, serious adverse events	AC Then T	264	1,305
Total, serious adverse events	AC Then XT	200	1,283

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34037241	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
AC Then T vs AC Then XT: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00089479

GET https://conductscience.org/api/trials/v1/NCT00089479/results?page=2

API reference For AI assistants