Trial · NCT00438100

Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer

NCT00438100, Phase 2, Completed, Japan Breast Cancer Research Network; results first posted 2015-05-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer. Trials, record NCT00438100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00438100

On this page

Trial

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

Title: Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
NCT number: NCT00438100
Status: Completed
Phases: Phase 2
Enrollment: 142 participants, actual
Lead sponsor: Japan Breast Cancer Research Network
Conditions: Breast Neoplasms
Interventions: Capecitabine, S-1
First posted: 2007-02-21
Last updated: 2015-05-29
Results first posted: 2015-05-29

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame
Primary	Progression Free Survival	The follow up period will be two years after the last dose has been administered.
Secondary	Adverse Events	The follow up period will be two years after the last dose has been administered.
Secondary	Antitumor Effects	The follow up period will be two years after the last dose has been administered.
Secondary	Time to Treatment Failure	The follow up period will be two years after the last dose has been administered.
Secondary	Survival Rate	The follow up period will be two years after the last dose has been administered.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression Free Survival	The follow up period will be two years after the last dose has been administered.	years	MEDIAN
SECONDARY	Adverse Events	The follow up period will be two years after the last dose has been administered.
SECONDARY	Antitumor Effects	The follow up period will be two years after the last dose has been administered.
SECONDARY	Time to Treatment Failure	The follow up period will be two years after the last dose has been administered.
SECONDARY	Survival Rate	The follow up period will be two years after the last dose has been administered.

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival	Capecitabine Arm		1.2	95% Confidence Interval 0.76 to 2.04	years
Progression Free Survival	S-1 Arm		1.3	95% Confidence Interval 0.96 to 2.68	years

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Capecitabine Arm	73
Overall Study	STARTED	S-1 Arm	69
Overall Study	COMPLETED	Capecitabine Arm	71
Overall Study	COMPLETED	S-1 Arm	65
Overall Study	NOT COMPLETED	Capecitabine Arm	2
Overall Study	NOT COMPLETED	S-1 Arm	4

Source ClinicalTrials.gov

Adverse events24

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	Thrombocytopenia	Investigations	Capecitabine Arm	1	71
other	Thrombocytopenia	Investigations	S-1 Arm	6	65
other	Nausea	Gastrointestinal disorders	Capecitabine Arm	10	71
other	Nausea	Gastrointestinal disorders	S-1 Arm	17	65
other	Hand-foot syndrome	Skin and subcutaneous tissue disorders	Capecitabine Arm	18	71
other	Hand-foot syndrome	Skin and subcutaneous tissue disorders	S-1 Arm	7	65
other	Anaemia	Blood and lymphatic system disorders	Capecitabine Arm	7	71
other	Anaemia	Blood and lymphatic system disorders	S-1 Arm	8	65
other	Leukopenia	Investigations	Capecitabine Arm	6	71
other	Leukopenia	Investigations	S-1 Arm	10	65

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Capecitabine Arm
Total, all-cause mortality	S-1 Arm
Total, other adverse events	Capecitabine Arm	44	71
Total, other adverse events	S-1 Arm	45	65
Total, serious adverse events	Capecitabine Arm	0	71
Total, serious adverse events	S-1 Arm	0	65

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Capecitabine Arm vs S-1 Arm: 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/NCT00438100

GET https://conductscience.org/api/trials/v1/NCT00438100/events?page=2

API reference For AI assistants