Trial · NCT02614794
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
NCT02614794, Phase 2, Completed, Seagen Inc.; results first posted 2020-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer. Trials, record NCT02614794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02614794
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
- NCT number
- NCT02614794
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 612 participants, actual
- Lead sponsor
- Seagen Inc.
- Conditions
- HER2 Positive Breast Cancer
- Interventions
- tucatinib, capecitabine, trastuzumab, placebo
- First posted
- 2015-11-25
- Last updated
- 2023-08-14
- Other registries' IDs
- eudract:2015-002801-12
- Results first posted
- 2020-09-28
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression. |
| Secondary | PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression. |
| Secondary | Overall Survival (OS) at Time of Primary Analysis | 35.9 months | Defined as time from randomization to death from any cause |
| Secondary | Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR | 34.6 months | Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR). |
| Secondary | ORR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | Defined as achieving a best overall response of confirmed CR or confirmed PR. |
| Secondary | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR | 24.6 months | Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. |
| Secondary | DOR Per RECIST 1.1 as Determined by Investigator Assessment | 33.2 months | Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. |
| Secondary | Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1 | 34.6 months | Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (PR). |
| Secondary | CBR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | Clinical benefit was defined as achieving stable disease (SD) or non-CR/non-PD for at least 6 months or a best overall response of confirmed CR or confirmed PR. |
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 | Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) | 34.6 months | Intent-to-treat Progression Free Survival (ITT-PFS) Population: Includes the first 480 randomized participants in the ITT analysis population (evaluated by their random treatment assignment). | months | MEDIAN |
| SECONDARY | PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR | 34.6 months | ITT-PFSBrainMets population: included all randomized participants with brain metastases (evaluated by their random treatment assignment). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) at Time of Primary Analysis | 35.9 months | ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment. | months | MEDIAN |
| SECONDARY | Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR | 34.6 months | ITT - PFS population, subset of participants with measurable disease by BICR at baseline. The ITT-PFS Population includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment). | percentage of participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | ITT - PFS population, subset of participants with measurable disease by investigator at baseline. The ITT-PFS Population includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment). | percentage of participants | NUMBER |
| SECONDARY | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis | 34.6 months | ITT-PFS Population: Includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment). | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR | 24.6 months | ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment. | months | MEDIAN |
| SECONDARY | DOR Per RECIST 1.1 as Determined by Investigator Assessment | 33.2 months | ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1 | 34.6 months | ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | CBR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) | Tuc+Cap+Tra | 7.8 | Inter-Quartile Range 4.3 to 17.8 | months | |
| Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) | Pbo+Cap+Tra | 5.6 | Inter-Quartile Range 3.0 to 9.7 | months | |
| PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR | Tuc+Cap+Tra | 7.6 | Inter-Quartile Range 4.2 to 11.8 | months | |
| PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR | Pbo+Cap+Tra | 5.4 | Inter-Quartile Range 3.0 to 7.5 | months | |
| Overall Survival (OS) at Time of Primary Analysis | Tuc+Cap+Tra | 21.9 | 95% Confidence Interval 18.3 to 31.0 | months | |
| Overall Survival (OS) at Time of Primary Analysis | Pbo+Cap+Tra | 17.4 | 95% Confidence Interval 13.6 to 19.9 | months | |
| Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR | Tuc+Cap+Tra | 40.7 | 95% Confidence Interval 34.8 to 46.7 | percentage of participants | |
| Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR | Pbo+Cap+Tra | 23.4 | 95% Confidence Interval 16.6 to 31.3 | percentage of participants | |
| ORR Per RECIST 1.1 as Determined by Investigator Assessment | Tuc+Cap+Tra | 41.4 | 95% Confidence Interval 35.6 to 47.4 | percentage of participants | |
| ORR Per RECIST 1.1 as Determined by Investigator Assessment | Pbo+Cap+Tra | 23.0 | 95% Confidence Interval 16.3 to 30.9 | percentage of 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 | Tuc+Cap+Tra | 410 | |
| Overall Study | STARTED | Pbo+Cap+Tra | 202 | |
| Overall Study | COMPLETED | Tuc+Cap+Tra | 0 | |
| Overall Study | COMPLETED | Pbo+Cap+Tra | 0 | |
| Overall Study | NOT COMPLETED | Tuc+Cap+Tra | 410 | |
| Overall Study | NOT COMPLETED | Pbo+Cap+Tra | 202 |
Source ClinicalTrials.gov
Adverse events446
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 | Tuc+Cap+Tra | 89 | 404 | 146 |
| other | Anaemia | Blood and lymphatic system disorders | Pbo+Cap+Tra | 24 | 197 | 32 |
| other | Neutropenia | Blood and lymphatic system disorders | Tuc+Cap+Tra | 37 | 404 | 87 |
| other | Neutropenia | Blood and lymphatic system disorders | Pbo+Cap+Tra | 17 | 197 | 40 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tuc+Cap+Tra | 27 | 404 | 41 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pbo+Cap+Tra | 11 | 197 | 15 |
| other | Dry eye | Eye disorders | Tuc+Cap+Tra | 23 | 404 | 25 |
| other | Dry eye | Eye disorders | Pbo+Cap+Tra | 10 | 197 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Tuc+Cap+Tra | 27 | 404 | 30 |
| other | Abdominal distension | Gastrointestinal disorders | Pbo+Cap+Tra | 10 | 197 | 13 |
1 to 10 of 446Source ClinicalTrials.gov
See all 446 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tuc+Cap+Tra | 262 | 410 |
| Total, all-cause mortality | Pbo+Cap+Tra | 152 | 202 |
| Total, other adverse events | Tuc+Cap+Tra | 399 | 404 |
| Total, other adverse events | Pbo+Cap+Tra | 188 | 197 |
| Total, serious adverse events | Tuc+Cap+Tra | 124 | 404 |
| Total, serious adverse events | Pbo+Cap+Tra | 62 | 197 |
Source ClinicalTrials.gov
Papers6
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 |
|---|---|
| Tuc+Cap+Tra vs Pbo+Cap+Tra: deaths from any cause | Trial comparisons |
| Tuc+Cap+Tra vs Pbo+Cap+Tra: 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/NCT02614794
GET https://conductscience.org/api/trials/v1/NCT02614794/results?page=2