Trial · NCT00878709
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
NCT00878709, Phase 3, Completed, Puma Biotechnology, Inc.; results first posted 2017-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer. Trials, record NCT00878709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
- NCT number
- NCT00878709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,840 participants, actual
- Lead sponsor
- Puma Biotechnology, Inc.
- Conditions
- Breast Cancer
- Interventions
- neratinib, placebo
- First posted
- 2009-04-09
- Last updated
- 2021-06-11
- Results first posted
- 2017-10-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. |
| Primary | Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | |
| Secondary | Overall Survival (OS) | Randomization until death due to any cause (up to 119 Months) | OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. |
| Secondary | Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any. |
| Secondary | Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | |
| Secondary | Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause. |
| Secondary | Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | |
| Secondary | Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer. |
| Secondary | Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | |
| Secondary | Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence. |
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 | Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| PRIMARY | Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Randomization until death due to any cause (up to 119 Months) | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | Neratinib | 4.7 | percentage of participants with events | ||
| Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | Placebo | 7.5 | percentage of participants with events | ||
| Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms | Neratinib | 94.2 | 95% Confidence Interval 92.6 to 95.4 | percentage of participants | |
| Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms | Placebo | 91.9 | 95% Confidence Interval 90.2 to 93.2 | percentage of participants | |
| Overall Survival (OS) | Neratinib | 1 Year Kaplan-Meier Estimate | 99.64 | 95% Confidence Interval 99.13 to 99.85 | percentage of participants |
| Overall Survival (OS) | Placebo | 1 Year Kaplan-Meier Estimate | 99.43 | 95% Confidence Interval 98.86 to 99.71 | percentage of participants |
| Overall Survival (OS) | Neratinib | 3 Year Kaplan-Meier Estimate | 96.74 | 95% Confidence Interval 95.62 to 97.57 | percentage of participants |
| Overall Survival (OS) | Placebo | 3 Year Kaplan-Meier Estimate | 96.44 | 95% Confidence Interval 95.30 to 97.31 | percentage of participants |
| Overall Survival (OS) | Neratinib | 5 Year Kaplan-Meier Estimate | 94.09 | 95% Confidence Interval 92.65 to 95.25 | percentage of participants |
| Overall Survival (OS) | Placebo | 5 Year Kaplan-Meier Estimate | 93.26 | 95% Confidence Interval 91.77 to 94.49 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neratinib | 1,420 | |
| Overall Study | STARTED | Placebo | 1,420 | |
| Overall Study | COMPLETED | Neratinib | 1,095 | |
| Overall Study | COMPLETED | Placebo | 1,183 | |
| Overall Study | NOT COMPLETED | Neratinib | 325 | |
| Overall Study | NOT COMPLETED | Placebo | 237 |
Source ClinicalTrials.gov
Adverse events372
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 | Diarrhoea | Gastrointestinal disorders | Neratinib | 1,341 | 1,408 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 499 | 1,408 | |
| other | Nausea | Gastrointestinal disorders | Neratinib | 605 | 1,408 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 303 | 1,408 | |
| other | Vomiting | Gastrointestinal disorders | Neratinib | 364 | 1,408 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 113 | 1,408 | |
| other | Abdominal pain | Gastrointestinal disorders | Neratinib | 339 | 1,408 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 144 | 1,408 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Neratinib | 212 | 1,408 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 96 | 1,408 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neratinib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Neratinib | 1,386 | 1,408 |
| Total, other adverse events | Placebo | 1,234 | 1,408 |
| Total, serious adverse events | Neratinib | 103 | 1,408 |
| Total, serious adverse events | Placebo | 85 | 1,408 |
Source ClinicalTrials.gov
Papers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Neratinib vs Placebo: 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/NCT00878709
GET https://conductscience.org/api/trials/v1/NCT00878709/results?page=2