Trial · NCT00878709
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 | From randomization until time of event up to 2 years | Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988). |
| Other | Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 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. |
| Other | Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 5 by Treatment Arms | From randomization until time of event up to 5 years | |
| Other | Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 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. |
| Other | Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 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. |
| Other | Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 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. |
| Other | Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5 | From randomization until time of event up to 5 years | Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00878709/registered