Trial · NCT00600340
2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab
NCT00600340, Phase 3, Completed, Central European Cooperative Oncology Group; results first posted 2019-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab. Trials, record NCT00600340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600340
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab
- NCT number
- NCT00600340
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 564 participants, actual
- Lead sponsor
- Central European Cooperative Oncology Group
- Conditions
- Metastatic Breast Cancer
- Interventions
- Bevacizumab and Paclitaxel, Bevacizumab and Capecitabine
- First posted
- 2008-01-25
- Last updated
- 2019-12-30
- Results first posted
- 2019-12-30
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (PP Population) | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250. |
| Primary | Overall Survival (ITT Population) | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250. |
| Secondary | Observation Time (ITT Population) | Up to approximately 6 years | Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death. |
| Secondary | Best Overall Response (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase |
| Secondary | Best Overall Response (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase |
| Secondary | Unconfirmed Best Overall Response (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. |
| Secondary | Unconfirmed Best Overall Response (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. |
| Secondary | Objective Response Rate and Disease Control Rate (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase |
| Secondary | Objective Response Rate and Disease Control Rate (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase |
| Secondary | Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (PP Population) | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years | Per Protocol Population (PP) | months | MEDIAN |
| PRIMARY | Overall Survival (ITT Population) | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years | Intent-to-Treat Population (ITT) | months | MEDIAN |
| SECONDARY | Observation Time (ITT Population) | Up to approximately 6 years | Intention-to-Treat population | months | MEDIAN |
| SECONDARY | Best Overall Response (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | Intent-to-Treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | Per protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Unconfirmed Best Overall Response (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Unconfirmed Best Overall Response (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | PP population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate and Disease Control Rate (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate and Disease Control Rate (PP Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | PP population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population) | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. | ITT population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (PP Population) | Bevacizumab Plus Paclitaxel | 30.2 | 95% Confidence Interval 25.6 to 32.6 | months | |
| Overall Survival (PP Population) | Bevacizumab Plus Capecitabine | 26.1 | 95% Confidence Interval 22.3 to 29.0 | months | |
| Overall Survival (ITT Population) | Bevacizumab Plus Paclitaxel | 29.5 | 95% Confidence Interval 25.3 to 32.4 | months | |
| Overall Survival (ITT Population) | Bevacizumab Plus Capecitabine | 26.0 | 95% Confidence Interval 22.3 to 29.0 | months | |
| Observation Time (ITT Population) | Bevacizumab Plus Paclitaxel | 54.3 | 95% Confidence Interval 53.1 to 57.5 | months | |
| Observation Time (ITT Population) | Bevacizumab Plus Capecitabine | 55.7 | 95% Confidence Interval 53.7 to 58.1 | months | |
| Best Overall Response (ITT Population) | Bevacizumab Plus Paclitaxel | Complete response | 10 | Participants | |
| Best Overall Response (ITT Population) | Bevacizumab Plus Capecitabine | Complete response | 2 | Participants | |
| Best Overall Response (ITT Population) | Bevacizumab Plus Paclitaxel | Partial response | 115 | Participants | |
| Best Overall Response (ITT Population) | Bevacizumab Plus Capecitabine | Partial response | 74 | Participants |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab Plus Paclitaxel | 285 | |
| Overall Study | STARTED | Bevacizumab Plus Capecitabine | 279 | |
| Overall Study | COMPLETED | Bevacizumab Plus Paclitaxel | 285 | |
| Overall Study | COMPLETED | Bevacizumab Plus Capecitabine | 279 | |
| Overall Study | NOT COMPLETED | Bevacizumab Plus Paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab Plus Capecitabine | 0 |
Source ClinicalTrials.gov
Adverse events314
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 | Anaemia | Blood and lymphatic system disorders | Bevacizumab Plus Paclitaxel | 35 | 284 | 59 |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab Plus Capecitabine | 17 | 277 | 20 |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab Plus Paclitaxel | 46 | 284 | 127 |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab Plus Capecitabine | 6 | 277 | 8 |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab Plus Paclitaxel | 87 | 284 | 204 |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab Plus Capecitabine | 13 | 277 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab Plus Paclitaxel | 9 | 284 | 12 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab Plus Capecitabine | 19 | 277 | 26 |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab Plus Paclitaxel | 20 | 284 | 26 |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab Plus Capecitabine | 18 | 277 | 21 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab Plus Paclitaxel | 196 | 284 |
| Total, all-cause mortality | Bevacizumab Plus Capecitabine | 209 | 277 |
| Total, other adverse events | Bevacizumab Plus Paclitaxel | 264 | 284 |
| Total, other adverse events | Bevacizumab Plus Capecitabine | 240 | 277 |
| Total, serious adverse events | Bevacizumab Plus Paclitaxel | 65 | 284 |
| Total, serious adverse events | Bevacizumab Plus Capecitabine | 68 | 277 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bevacizumab Plus Paclitaxel vs Bevacizumab Plus Capecitabine: deaths from any cause | Trial comparisons |
| Bevacizumab Plus Paclitaxel vs Bevacizumab Plus Capecitabine: serious adverse events | 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/NCT00600340
GET https://conductscience.org/api/trials/v1/NCT00600340/results?page=2