Trial · NCT00374322
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis]) | Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Died (Overall Survival) | From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis]) | ITT Population. Data for the primary analysis (conducted in 2011) are reported. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence) | From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis]) | ITT Population. Data for the primary analysis (conducted in 2011) are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence) | From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis]) | ITT Population. Data for the primary analysis (conducted in 2011) are reported. | Percentage of participants | NUMBER |
| SECONDARY | Time to Central Nervous System (CNS) Recurrence | From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis]) | |||
| SECONDARY | Number of Participants With CNS Recurrence | From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis]) | ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported. | Participants | NUMBER |
| SECONDARY | Modified Disease-free Survival (MDFS) | From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years) | |||
| SECONDARY | Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years) | ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS) | Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) | ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS) | Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) | ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH) | Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years) | ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters | At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit | Safety Population (SP): all randomized participants (par.) who received \>=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters | At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit | Safety Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades | From the first dose of study treatment up to 12 months | Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported. | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Primary or Secondary Cardiac Events | From the date of randomization up to 12 months | Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported. | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Electrocardiogram (ECG) Findings | Screening and Month 12/Early Withdrawal Visit | SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. | Participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT00374322/outcomes