Trial · NCT01702571
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
NCT01702571, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment. Trials, record NCT01702571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01702571
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
- NCT number
- NCT01702571
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,185 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab Emtansine
- First posted
- 2012-10-08
- Last updated
- 2022-04-04
- Other registries' IDs
- eudract:2012-001628-37
- Results first posted
- 2021-08-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events of Primary Interest (AEPIs) | Baseline up to approximately 7 years | The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades. |
| Secondary | Percentage of Participants With Specific AEPIs | Baseline up to approximately 7 years | The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades. |
| Secondary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Baseline up to approximately 7 years | AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were \>3 × ULN, Concurrent elevation of total bilirubin \>2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin \>2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product. |
| Secondary | Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). |
| Secondary | Overall Survival | Baseline until death (up to approximately 7 years) | Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death. |
| Secondary | Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. |
| Secondary | Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. |
| Secondary | Duration of Response (DOR) According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). |
| Secondary | Time to Response According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. |
| Secondary | Number of Hospital Visits | Baseline up to approximately 7 years | The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Adverse Events of Primary Interest (AEPIs) | Baseline up to approximately 7 years | The safety population included all participants who had received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Specific AEPIs | Baseline up to approximately 7 years | The safety population included all participants who had received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Baseline up to approximately 7 years | The safety population included all participants who had received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | Intent to Treat (ITT) Population included all participants enrolled in the study. | months | MEDIAN |
| SECONDARY | Overall Survival | Baseline until death (up to approximately 7 years) | ITT Population included all participants enrolled in the study. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis. | months | MEDIAN |
| SECONDARY | Time to Response According to RECIST v 1.1 | Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years) | ITT Population included all participants enrolled in the study. Only responders were included in the analysis. | months | MEDIAN |
| SECONDARY | Number of Hospital Visits | Baseline up to approximately 7 years | The safety population included all participants who had received at least 1 dose of study medication. | Number of Hospital Visits | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
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 Adverse Events of Primary Interest (AEPIs) | Trastuzumab Emtansine (All Participants) | 23.1 | 95% Confidence Interval 21.2 to 25.0 | Percentage of Participants | |
| Percentage of Participants With Adverse Events of Primary Interest (AEPIs) | Trastuzumab Emtansine (Asian Participants) | 51.4 | 95% Confidence Interval 43.9 to 58.9 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (All Participants) | AEs Grade >/= 3 for hepatic events | 6.9 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (Asian Participants) | AEs Grade >/= 3 for hepatic events | 12.2 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (All Participants) | AEs Grade >/= 3 for allergic reactions | 2.3 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (Asian Participants) | AEs Grade >/= 3 for allergic reactions | 1.1 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (All Participants) | AEs Grade >/= 3 for thrombocytopenia | 3.7 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (Asian Participants) | AEs Grade >/= 3 for thrombocytopenia | 36.5 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (All Participants) | AEs Grade >/= 3 for hemorrhage events | 2.3 | Percentage of Participants | |
| Percentage of Participants With Specific AEPIs | Trastuzumab Emtansine (Asian Participants) | AEs Grade >/= 3 for hemorrhage events | 1.7 | Percentage of Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trastuzumab Emtansine (All Participants) | 2,003 | |
| Overall Study | STARTED | Trastuzumab Emtansine (Asian Participants) | 182 | |
| Overall Study | COMPLETED | Trastuzumab Emtansine (All Participants) | 494 | |
| Overall Study | COMPLETED | Trastuzumab Emtansine (Asian Participants) | 65 | |
| Overall Study | NOT COMPLETED | Trastuzumab Emtansine (All Participants) | 1,509 | |
| Overall Study | NOT COMPLETED | Trastuzumab Emtansine (Asian Participants) | 117 |
Source ClinicalTrials.gov
Adverse events680
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 (All Participants) | 173 | 2,002 | 231 |
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (Asian Participants) | 27 | 181 | 49 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (All Participants) | 19 | 2,002 | 23 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (Asian Participants) | 15 | 181 | 69 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (All Participants) | 79 | 2,002 | 151 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (Asian Participants) | 17 | 181 | 72 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (All Participants) | 165 | 2,002 | 257 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Trastuzumab Emtansine (Asian Participants) | 47 | 181 | 157 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Trastuzumab Emtansine (All Participants) | 139 | 2,002 | 182 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Trastuzumab Emtansine (Asian Participants) | 6 | 181 | 8 |
1 to 10 of 680Source ClinicalTrials.gov
See all 680 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab Emtansine (All Participants) | 1,072 | 2,002 |
| Total, all-cause mortality | Trastuzumab Emtansine (Asian Participants) | 77 | 181 |
| Total, other adverse events | Trastuzumab Emtansine (All Participants) | 1,734 | 2,002 |
| Total, other adverse events | Trastuzumab Emtansine (Asian Participants) | 170 | 181 |
| Total, serious adverse events | Trastuzumab Emtansine (All Participants) | 427 | 2,002 |
| Total, serious adverse events | Trastuzumab Emtansine (Asian Participants) | 36 | 181 |
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 |
|---|---|
| Trastuzumab Emtansine (All Participants) vs Trastuzumab Emtansine (Asian Participants): deaths from any cause | Trial comparisons |
| Trastuzumab Emtansine (All Participants) vs Trastuzumab Emtansine (Asian Participants): 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.
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GET https://conductscience.org/api/trials/v1/NCT01702571/results?page=2