Trial · NCT00082433
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
NCT00082433, Phase 3, Completed, R-Pharm; results first posted 2009-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer. Trials, record NCT00082433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00082433
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
- NCT number
- NCT00082433
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,221 participants, actual
- Lead sponsor
- R-Pharm
- Conditions
- Cancer, Breast Cancer
- Interventions
- Ixabepilone + Capecitabine, Capecitabine
- First posted
- 2004-05-11
- Last updated
- 2020-11-02
- Results first posted
- 2009-08-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | from date of randomization until death | Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method. |
| Secondary | Progression-Free Survival (PFS) | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment. |
| Secondary | Response Rate (RR) | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants |
| Secondary | Duration of Response | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method. |
| Secondary | Time to Response | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure). |
| Secondary | Treatment-Related Safety Summary | safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. | Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0 |
| Secondary | Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) | Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment | Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression-Free Survival (PFS) | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants. | months | MEDIAN |
| SECONDARY | Response Rate (RR) | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline). | percentage of participants | MEAN |
| SECONDARY | Duration of Response | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline) | Months | MEDIAN |
| SECONDARY | Time to Response | every 6 weeks (± 3 days) from randomization while on treatment until documented progression | Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline) | weeks | MEDIAN |
| SECONDARY | Treatment-Related Safety Summary | safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. | All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046. | Participants | NUMBER |
| SECONDARY | Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) | Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment | Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.) | units on a scale | MEAN |
| PRIMARY | Overall Survival (OS) | from date of randomization until death | Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Ixabepilone + Capecitabine | 6.24 | 95% Confidence Interval 5.59 to 6.77 | months | |
| Progression-Free Survival (PFS) | Capecitabine | 4.40 | 95% Confidence Interval 4.14 to 5.42 | months | |
| Response Rate (RR) | Ixabepilone + Capecitabine | 43.3 | 95% Confidence Interval 38.7 to 47.9 | percentage of participants | |
| Response Rate (RR) | Capecitabine | 28.8 | 95% Confidence Interval 24.7 to 33.2 | percentage of participants | |
| Duration of Response | Ixabepilone + Capecitabine | 6.1 | 95% Confidence Interval 5.5 to 7.0 | Months | |
| Duration of Response | Capecitabine | 6.3 | 95% Confidence Interval 5.3 to 7.6 | Months | |
| Time to Response | Ixabepilone + Capecitabine | 6.6 | Full Range 4.7 to 47.9 | weeks | |
| Time to Response | Capecitabine | 6.6 | Full Range 4.6 to 59.4 | weeks | |
| Treatment-Related Safety Summary | Ixabepilone + Capecitabine | Deaths within 30 days of last dose | 19 | Participants | |
| Treatment-Related Safety Summary | Capecitabine | Deaths within 30 days of last dose | 42 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixabepilone + Capecitabine | 609 | |
| Overall Study | STARTED | Capecitabine | 612 | |
| Overall Study | COMPLETED | Ixabepilone + Capecitabine | 15 | |
| Overall Study | COMPLETED | Capecitabine | 15 | |
| Overall Study | NOT COMPLETED | Ixabepilone + Capecitabine | 594 | |
| Overall Study | NOT COMPLETED | Capecitabine | 597 |
Source ClinicalTrials.gov
Adverse events566
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 | Events |
|---|---|---|---|---|---|---|
| other | WEIGHT DECREASED | Investigations | Capecitabine | 104 | 603 | |
| other | WEIGHT DECREASED | Investigations | Ixabepilone + Capecitabine | 194 | 595 | |
| other | WEIGHT INCREASED | Investigations | Capecitabine | 47 | 603 | |
| other | WEIGHT INCREASED | Investigations | Ixabepilone + Capecitabine | 26 | 595 | |
| other | HAEMOGLOBIN DECREASED | Investigations | Capecitabine | 22 | 603 | |
| other | HAEMOGLOBIN DECREASED | Investigations | Ixabepilone + Capecitabine | 44 | 595 | |
| other | PLATELET COUNT DECREASED | Investigations | Capecitabine | 13 | 603 | |
| other | PLATELET COUNT DECREASED | Investigations | Ixabepilone + Capecitabine | 33 | 595 | |
| other | NEUTROPHIL COUNT DECREASED | Investigations | Capecitabine | 21 | 603 | |
| other | NEUTROPHIL COUNT DECREASED | Investigations | Ixabepilone + Capecitabine | 67 | 595 |
1 to 10 of 566Source ClinicalTrials.gov
See all 566 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine | ||
| Total, all-cause mortality | Ixabepilone + Capecitabine | ||
| Total, other adverse events | Capecitabine | 564 | 603 |
| Total, other adverse events | Ixabepilone + Capecitabine | 590 | 595 |
| Total, serious adverse events | Capecitabine | 192 | 603 |
| Total, serious adverse events | Ixabepilone + Capecitabine | 205 | 595 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 vs Ixabepilone + Capecitabine: 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.
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/NCT00082433
GET https://conductscience.org/api/trials/v1/NCT00082433/results?page=2