Trial · NCT00829166
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
NCT00829166, Phase 3, Completed, Hoffmann-La Roche; results first posted 2013-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer. Trials, record NCT00829166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00829166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT00829166
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 991 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab emtansine, Lapatinib, Capecitabine
- First posted
- 2009-01-26
- Last updated
- 2016-10-31
- Results first posted
- 2013-04-23
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported. |
| Primary | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. |
| Primary | Percentage of Participants Who Died: Second Interim Analysis | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory. |
| Primary | Overall Survival: Second Interim Analysis (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory. |
| Primary | Percentage of Participants Who Died: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive. |
| Primary | Overall Survival: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive. |
| Primary | Percentage of Participants Who Were Alive at Year 1 | Year 1 | 1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis. |
| Primary | Percentage of Participants Who Were Alive at Year 2 | Year 2 | 2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis. |
| Secondary | Percentage of Participants With PD or Death as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported. |
| Secondary | PFS as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. |
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 | Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died: Second Interim Analysis | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival: Second Interim Analysis (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Were Alive at Year 1 | Year 1 | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Were Alive at Year 2 | Year 2 | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PD or Death as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | Trastuzumab Emtansine | 53.5 | percentage of participants | ||
| Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | Lapatinib + Capecitabine | 61.3 | percentage of participants | ||
| Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | Trastuzumab Emtansine | 9.6 | 95% Confidence Interval 8.25 to 10.64 | Months | |
| Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | Lapatinib + Capecitabine | 6.4 | 95% Confidence Interval 5.68 to 7.06 | Months | |
| Percentage of Participants Who Died: Second Interim Analysis | Trastuzumab Emtansine | 30.1 | percentage of participants | ||
| Percentage of Participants Who Died: Second Interim Analysis | Lapatinib + Capecitabine | 36.7 | percentage of participants | ||
| Overall Survival: Second Interim Analysis (Co-primary Endpoint) | Trastuzumab Emtansine | 30.9 | 95% Confidence Interval 26.81 to 34.27 | Months | |
| Overall Survival: Second Interim Analysis (Co-primary Endpoint) | Lapatinib + Capecitabine | 25.1 | 95% Confidence Interval 22.74 to 27.96 | Months | |
| Percentage of Participants Who Died: Final Analysis | Trastuzumab Emtansine | 61.2 | percentage of participants | ||
| Percentage of Participants Who Died: Final Analysis | Lapatinib + Capecitabine | 67.1 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trastuzumab Emtansine | 495 | |
| Overall Study | STARTED | Lapatinib + Capecitabine | 496 | |
| Overall Study | Treated | Trastuzumab Emtansine | 490 | |
| Overall Study | Treated | Lapatinib + Capecitabine | 488 | |
| Overall Study | COMPLETED | Trastuzumab Emtansine | 0 | |
| Overall Study | COMPLETED | Lapatinib + Capecitabine | 0 | |
| Overall Study | NOT COMPLETED | Trastuzumab Emtansine | 495 | |
| Overall Study | NOT COMPLETED | Lapatinib + Capecitabine | 496 |
Source ClinicalTrials.gov
Adverse events717
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 | Trastuzumab Emtansine | 67 | 490 | |
| other | Anaemia | Blood and lymphatic system disorders | Lapatinib + Capecitabine | 40 | 488 | |
| other | Anaemia | Blood and lymphatic system disorders | Lapatinib + Capecitabine/ Trastuzumab Emtansine | 11 | 136 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trastuzumab Emtansine | 37 | 490 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lapatinib + Capecitabine | 43 | 488 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lapatinib + Capecitabine/ Trastuzumab Emtansine | 0 | 136 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trastuzumab Emtansine | 150 | 490 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lapatinib + Capecitabine | 13 | 488 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lapatinib + Capecitabine/ Trastuzumab Emtansine | 23 | 136 | |
| other | Dry eye | Eye disorders | Trastuzumab Emtansine | 0 | 490 |
1 to 10 of 717Source ClinicalTrials.gov
See all 717 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab Emtansine | ||
| Total, all-cause mortality | Lapatinib + Capecitabine | ||
| Total, all-cause mortality | Lapatinib + Capecitabine/ Trastuzumab Emtansine | ||
| Total, other adverse events | Trastuzumab Emtansine | 474 | 490 |
| Total, other adverse events | Lapatinib + Capecitabine | 471 | 488 |
| Total, other adverse events | Lapatinib + Capecitabine/ Trastuzumab Emtansine | 115 | 136 |
| Total, serious adverse events | Trastuzumab Emtansine | 92 | 490 |
| Total, serious adverse events | Lapatinib + Capecitabine | 99 | 488 |
| Total, serious adverse events | Lapatinib + Capecitabine/ Trastuzumab Emtansine | 19 | 136 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00829166
GET https://conductscience.org/api/trials/v1/NCT00829166/results?page=2