Trial · NCT01808573
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
NCT01808573, Phase 3, Completed, Puma Biotechnology, Inc.; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting. Trials, record NCT01808573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01808573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
- NCT number
- NCT01808573
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 621 participants, actual
- Lead sponsor
- Puma Biotechnology, Inc.
- Conditions
- HER2+ Metastatic Breast Cancer (MBC)
- Interventions
- neratinib, capecitabine, lapatinib
- First posted
- 2013-03-11
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2012-004492-38
- Results first posted
- 2019-12-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centrally Assessed Progression Free Survival | From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut. | Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), 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. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months. |
| Primary | Overall Survival | From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut. | Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months. |
| Secondary | Intervention for Symptomatic Metastatic Central Nervous System Disease | From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut. | Intervention for symptomatic metastatic central nervous system disease is defined as the time from randomization to the first start date of an intervention for symptomatic metastatic CNS disease. Subjects that do not have an intervention for symptomatic metastatic CNS and do not die will be censored at the last date known alive on or prior to the data cutoff. Deaths are treated as competing events. Percentage of participants with intervention for CNS, estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring. |
| Secondary | Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) | From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut. | Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. 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) - Central Assessment (ITT Population With Measurable Disease at Screening) | From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut. | Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening. |
| Secondary | Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening) | From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut. | The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening. Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) | From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut. | Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Centrally Assessed Progression Free Survival | From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut. | Randomized ITT Population | months | MEAN |
| PRIMARY | Overall Survival | From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut. | months | MEAN | |
| SECONDARY | Intervention for Symptomatic Metastatic Central Nervous System Disease | From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut. | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) | From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut. | percentage of participants | NUMBER | |
| SECONDARY | Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) | From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut. | percentage of participants | NUMBER | |
| SECONDARY | Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening) | From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut. | months | MEDIAN | |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) | From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut. | Safety population: Participants receiving at least 1 dose of investigational product. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Centrally Assessed Progression Free Survival | Neratinib Plus Capecitabine | 8.8 | 95% Confidence Interval 7.8 to 9.8 | months | |
| Centrally Assessed Progression Free Survival | Lapatinib Plus Capecitabine | 6.6 | 95% Confidence Interval 5.9 to 7.4 | months | |
| Overall Survival | Neratinib Plus Capecitabine | 24.0 | 95% Confidence Interval 22.1 to 25.9 | months | |
| Overall Survival | Lapatinib Plus Capecitabine | 22.2 | 95% Confidence Interval 20.4 to 24.0 | months | |
| Intervention for Symptomatic Metastatic Central Nervous System Disease | Neratinib Plus Capecitabine | 22.76 | 95% Confidence Interval 15.48 to 30.91 | percentage of participants | |
| Intervention for Symptomatic Metastatic Central Nervous System Disease | Lapatinib Plus Capecitabine | 29.19 | 95% Confidence Interval 22.54 to 36.14 | percentage of participants | |
| Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) | Neratinib Plus Capecitabine | 32.8 | 95% Confidence Interval 27.1 to 38.9 | percentage of participants | |
| Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) | Lapatinib Plus Capecitabine | 26.7 | 95% Confidence Interval 21.5 to 32.4 | percentage of participants | |
| Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) | Neratinib Plus Capecitabine | 44.5 | 95% Confidence Interval 38.3 to 50.8 | percentage of participants | |
| Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) | Lapatinib Plus Capecitabine | 35.6 | 95% Confidence Interval 29.8 to 41.6 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neratinib Plus Capecitabine | 307 | |
| Overall Study | STARTED | Lapatinib Plus Capecitabine | 314 | |
| Overall Study | Received Treatment | Neratinib Plus Capecitabine | 303 | |
| Overall Study | Received Treatment | Lapatinib Plus Capecitabine | 311 | |
| Overall Study | COMPLETED | Neratinib Plus Capecitabine | 0 | |
| Overall Study | COMPLETED | Lapatinib Plus Capecitabine | 0 | |
| Overall Study | NOT COMPLETED | Neratinib Plus Capecitabine | 307 | |
| Overall Study | NOT COMPLETED | Lapatinib Plus Capecitabine | 314 |
Source ClinicalTrials.gov
Adverse events400
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 | Neratinib Plus Capecitabine | 45 | 303 | |
| other | Anaemia | Blood and lymphatic system disorders | Lapatinib Plus Capecitabine | 50 | 311 | |
| other | Neutropenia | Blood and lymphatic system disorders | Neratinib Plus Capecitabine | 23 | 303 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lapatinib Plus Capecitabine | 16 | 311 | |
| other | Abdominal distension | Gastrointestinal disorders | Neratinib Plus Capecitabine | 25 | 303 | |
| other | Abdominal distension | Gastrointestinal disorders | Lapatinib Plus Capecitabine | 9 | 311 | |
| other | Abdominal pain | Gastrointestinal disorders | Neratinib Plus Capecitabine | 37 | 303 | |
| other | Abdominal pain | Gastrointestinal disorders | Lapatinib Plus Capecitabine | 42 | 311 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Neratinib Plus Capecitabine | 18 | 303 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Lapatinib Plus Capecitabine | 28 | 311 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neratinib Plus Capecitabine | 219 | 307 |
| Total, all-cause mortality | Lapatinib Plus Capecitabine | 243 | 314 |
| Total, other adverse events | Neratinib Plus Capecitabine | 301 | 303 |
| Total, other adverse events | Lapatinib Plus Capecitabine | 309 | 311 |
| Total, serious adverse events | Neratinib Plus Capecitabine | 103 | 303 |
| Total, serious adverse events | Lapatinib Plus Capecitabine | 93 | 311 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|
| Neratinib Plus Capecitabine vs Lapatinib Plus Capecitabine: deaths from any cause | Trial comparisons |
| Neratinib Plus Capecitabine vs Lapatinib Plus Capecitabine: 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/NCT01808573
GET https://conductscience.org/api/trials/v1/NCT01808573/events?page=2