Trial · NCT00876395
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
NCT00876395, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer. Trials, record NCT00876395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00876395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT00876395
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 719 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- Everolimus, Placebo, Trastuzumab, Paclitaxel
- First posted
- 2009-04-06
- Last updated
- 2018-12-19
- Other registries' IDs
- eudract:2008-006556-21
- Results first posted
- 2018-12-19
- Limitations and caveats
- Of the 480 patients enrolled in the Everolimus arm, 8 were untreated and in the Placebo arm, of the 239 patients enrolled, 1 was untreated.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population. |
| Primary | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population. |
| Secondary | Overall Survival (OS) - Full Population | up to about 76 months | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population. |
| Secondary | Overall Survival (OS) - HR-negative Population | up to about 76 months | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population. |
| Secondary | Overall Response Rate (ORR) - Full Population | up to about 23 months | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
| Secondary | Overall Response Rate (ORR) - HR-negative Population | up to about 23 months | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
| Secondary | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population | up to about 23 months | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
| Secondary | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population | up to about 23 months | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
| Secondary | Time to Overall Response Based on Investigator - Full Population | up to about 23 months | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
| Secondary | Time to Overall Response Based on Investigator - HR-negative Population | up to about 23 months | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Full Population | up to about 76 months | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. Due to the exploratory nature of the OS analysis, OS was not statistically tested | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - HR-negative Population | up to about 76 months | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. Due to the exploratory nature of the OS analysis, OS was not statistically tested. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) - Full Population | up to about 23 months | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) - HR-negative Population | up to about 23 months | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population | up to about 23 months | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population | up to about 23 months | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Percentage of participants | NUMBER |
| SECONDARY | Time to Overall Response Based on Investigator - Full Population | up to about 23 months | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | months | MEDIAN |
| SECONDARY | Time to Overall Response Based on Investigator - HR-negative Population | up to about 23 months | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group52
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) Per Investigators' Assessment Based on Local Radiology Review - Full Population | Everolimus + Paclitaxel + Trastuzumab | 14.95 | 95% Confidence Interval 14.55 to 17.91 | months | |
| Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population | Placebo + Paclitaxel + Trastuzumab | 14.49 | 95% Confidence Interval 12.29 to 17.08 | months | |
| Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | Everolimus + Paclitaxel + Trastuzumab | 20.27 | 95% Confidence Interval 14.95 to 24.08 | Months | |
| Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | Placebo + Paclitaxel + Trastuzumab | 13.08 | 95% Confidence Interval 10.05 to 16.56 | Months | |
| Overall Survival (OS) - Full Population | Everolimus + Paclitaxel + Trastuzumab | 48.56 | 95% Confidence Interval 40.94 to 58.94 | Months | |
| Overall Survival (OS) - Full Population | Placebo + Paclitaxel + Trastuzumab | 49.97 | 95% Confidence Interval 40.84 to NA | Months | |
| Overall Survival (OS) - HR-negative Population | Everolimus + Paclitaxel + Trastuzumab | 56.97 | 95% Confidence Interval 44.09 to NA | Months | |
| Overall Survival (OS) - HR-negative Population | Placebo + Paclitaxel + Trastuzumab | 41.63 | 95% Confidence Interval 34.83 to NA | Months | |
| Overall Response Rate (ORR) - Full Population | Everolimus + Paclitaxel + Trastuzumab | 67.1 | 95% Confidence Interval 62.7 to 71.3 | Percentage of participants | |
| Overall Response Rate (ORR) - Full Population | Placebo + Paclitaxel + Trastuzumab | 69.0 | 95% Confidence Interval 62.8 to 74.8 | Percentage of participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus + Paclitaxel + Trastuzumab | 480 | |
| Overall Study | STARTED | Placebo + Paclitaxel + Trastuzumab | 239 | |
| Overall Study | Untreated | Everolimus + Paclitaxel + Trastuzumab | 8 | |
| Overall Study | Untreated | Placebo + Paclitaxel + Trastuzumab | 1 | |
| Overall Study | COMPLETED | Everolimus + Paclitaxel + Trastuzumab | 0 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel + Trastuzumab | 0 | |
| Overall Study | NOT COMPLETED | Everolimus + Paclitaxel + Trastuzumab | 480 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel + Trastuzumab | 239 |
Source ClinicalTrials.gov
Adverse events592
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 | Everolimus+ Paclitaxel+ Trastuzumab | 143 | 472 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo+ Paclitaxel+ Trastuzumab | 38 | 238 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus+ Paclitaxel+ Trastuzumab | 71 | 472 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo+ Paclitaxel+ Trastuzumab | 24 | 238 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus+ Paclitaxel+ Trastuzumab | 177 | 472 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+ Paclitaxel+ Trastuzumab | 59 | 238 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus+ Paclitaxel+ Trastuzumab | 46 | 472 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo+ Paclitaxel+ Trastuzumab | 6 | 238 | |
| other | Left ventricular dysfunction | Cardiac disorders | Everolimus+ Paclitaxel+ Trastuzumab | 32 | 472 | |
| other | Left ventricular dysfunction | Cardiac disorders | Placebo+ Paclitaxel+ Trastuzumab | 10 | 238 |
1 to 10 of 592Source ClinicalTrials.gov
See all 592 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus+ Paclitaxel+ Trastuzumab | 23 | 472 |
| Total, all-cause mortality | Placebo+ Paclitaxel+ Trastuzumab | 2 | 238 |
| Total, other adverse events | Everolimus+ Paclitaxel+ Trastuzumab | 466 | 472 |
| Total, other adverse events | Placebo+ Paclitaxel+ Trastuzumab | 236 | 238 |
| Total, serious adverse events | Everolimus+ Paclitaxel+ Trastuzumab | 173 | 472 |
| Total, serious adverse events | Placebo+ Paclitaxel+ Trastuzumab | 40 | 238 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Everolimus+ Paclitaxel+ Trastuzumab vs Placebo+ Paclitaxel+ Trastuzumab: deaths from any cause | Trial comparisons |
| Everolimus+ Paclitaxel+ Trastuzumab vs Placebo+ Paclitaxel+ Trastuzumab: 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/NCT00876395
GET https://conductscience.org/api/trials/v1/NCT00876395/results?page=2