Trial · NCT01007942
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
NCT01007942, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer. Trials, record NCT01007942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01007942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT01007942
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 569 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Interventions
- everolimus, Placebo, vinorelbine, trastuzumab
- First posted
- 2009-11-04
- Last updated
- 2017-04-05
- Other registries' IDs
- eudract:2008-008697-31
- Results first posted
- 2017-04-05
- Limitations and caveats
All randomized patients were included in the FAS. Seven patients (4 in the everolimus arm \& 3 in the placebo arm) were randomized but never received treatment \& were therefore excluded from the Safety Set.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progressive-free Survival (PFS) Per Investigator Assessment | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | Every 3 months until death up to 41 months | OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred. |
| Secondary | Overall Response Rate (ORR) | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Clinical Benefit Rate (CBR) | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline. |
| Secondary | Median Time to Deterioration of the ECOG Performance Status Score | baseline, until disease progression or death up to about 41 months | Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead |
| Secondary | PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%) | Baseline, until disease progression or death up to about 41 months | PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here. |
| Secondary | Everolimus Blood Concentrations by Leading Dose and Time Point | Cycle 2, Day 1 | Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses. |
| Secondary | Vinorelbine Blood Concentrations by Leading Dose and Time Point | Cycle 2, Day 1 | Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses. |
| Secondary | Trastuzumab Blood Concentrations by Leading Dose and Time Point | Cycle 3, Day 1 | Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progressive-free Survival (PFS) Per Investigator Assessment | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Every 3 months until death up to 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Median Time to Deterioration of the ECOG Performance Status Score | baseline, until disease progression or death up to about 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | months | MEDIAN |
| SECONDARY | PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%) | Baseline, until disease progression or death up to about 41 months | The Full Analysis Set (FAS) consisted of all randomized patients. | months | MEDIAN |
| SECONDARY | Everolimus Blood Concentrations by Leading Dose and Time Point | Cycle 2, Day 1 | The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment. | ng/ml | MEAN |
| SECONDARY | Vinorelbine Blood Concentrations by Leading Dose and Time Point | Cycle 2, Day 1 | The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment. | ng/ml | MEAN |
| SECONDARY | Trastuzumab Blood Concentrations by Leading Dose and Time Point | Cycle 3, Day 1 | The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment. | ng/ml | MEAN |
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 |
|---|---|---|---|---|---|
| Progressive-free Survival (PFS) Per Investigator Assessment | Everolimus + Vinorelbine + Trastuzumab | 7.00 | 95% Confidence Interval 6.74 to 8.18 | months | |
| Progressive-free Survival (PFS) Per Investigator Assessment | Placebo + Vinorelbine + Trastuzumab | 5.78 | 95% Confidence Interval 5.49 to 6.90 | months | |
| Overall Survival (OS) | Everolimus + Vinorelbine + Trastuzumab | 23.46 | 95% Confidence Interval 20.01 to 28.81 | months | |
| Overall Survival (OS) | Placebo + Vinorelbine + Trastuzumab | 24.08 | 95% Confidence Interval 21.49 to 27.63 | months | |
| Overall Response Rate (ORR) | Everolimus + Vinorelbine + Trastuzumab | 40.8 | 95% Confidence Interval 35.1 to 46.8 | Percentage of participants | |
| Overall Response Rate (ORR) | Placebo + Vinorelbine + Trastuzumab | 37.2 | 95% Confidence Interval 31.6 to 43.1 | Percentage of participants | |
| Clinical Benefit Rate (CBR) | Everolimus + Vinorelbine + Trastuzumab | 59.2 | 95% Confidence Interval 53.2 to 64.9 | Percentage of participants | |
| Clinical Benefit Rate (CBR) | Placebo + Vinorelbine + Trastuzumab | 53.3 | 95% Confidence Interval 47.4 to 59.2 | Percentage of participants | |
| Median Time to Deterioration of the ECOG Performance Status Score | Everolimus + Vinorelbine + Trastuzumab | 32.66 | 95% Confidence Interval 17.68 to 32.66 | months | |
| Median Time to Deterioration of the ECOG Performance Status Score | Placebo + Vinorelbine + Trastuzumab | 21.55 | 95% Confidence Interval 12.48 to NA | months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus + Vinorelbine + Trastuzumab | 284 | |
| Overall Study | STARTED | Placebo + Vinorelbine + Trastuzumab | 285 | |
| Overall Study | COMPLETED | Everolimus + Vinorelbine + Trastuzumab | 3 | |
| Overall Study | COMPLETED | Placebo + Vinorelbine + Trastuzumab | 7 | |
| Overall Study | NOT COMPLETED | Everolimus + Vinorelbine + Trastuzumab | 281 | |
| Overall Study | NOT COMPLETED | Placebo + Vinorelbine + Trastuzumab | 278 |
Source ClinicalTrials.gov
Adverse events442
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 + Trastuzumab + Vinorelbine | 137 | 280 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Trastuzumab + Vinorelbine | 85 | 282 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Everolimus + Trastuzumab + Vinorelbine | 17 | 280 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo + Trastuzumab + Vinorelbine | 7 | 282 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus + Trastuzumab + Vinorelbine | 126 | 280 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Trastuzumab + Vinorelbine | 105 | 282 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus + Trastuzumab + Vinorelbine | 226 | 280 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Trastuzumab + Vinorelbine | 196 | 282 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus + Trastuzumab + Vinorelbine | 39 | 280 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Trastuzumab + Vinorelbine | 6 | 282 |
1 to 10 of 442Source ClinicalTrials.gov
See all 442 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus + Trastuzumab + Vinorelbine | ||
| Total, all-cause mortality | Placebo + Trastuzumab + Vinorelbine | ||
| Total, other adverse events | Everolimus + Trastuzumab + Vinorelbine | 280 | 280 |
| Total, other adverse events | Placebo + Trastuzumab + Vinorelbine | 280 | 282 |
| Total, serious adverse events | Everolimus + Trastuzumab + Vinorelbine | 122 | 280 |
| Total, serious adverse events | Placebo + Trastuzumab + Vinorelbine | 58 | 282 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24742739 | 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 |
|---|
| Everolimus + Trastuzumab + Vinorelbine vs Placebo + Trastuzumab + Vinorelbine: 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/NCT01007942
GET https://conductscience.org/api/trials/v1/NCT01007942/results?page=2