Trial · NCT00374322
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
NCT00374322, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer. Trials, record NCT00374322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00374322
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
- NCT number
- NCT00374322
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,166 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Breast
- Interventions
- lapatinib, placebo
- First posted
- 2006-09-11
- Last updated
- 2014-08-18
- Results first posted
- 2014-08-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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]) | DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed. |
| 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]) | Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive. |
| 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]) | Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS). |
| 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]) | Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence. |
| 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]) | Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table. |
| 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]) | The number of participants experiencing a CNS recurrence was summarized. |
| 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) | Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table. |
| 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) | DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed. |
| 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) | The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement. |
| 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) | The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group488
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Lapatinib 1500 mg | Any recurrence or death | 252 | Participants | |
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Placebo | Any recurrence or death | 290 | Participants | |
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Lapatinib 1500 mg | Censored, New Anti-cancer Agent/Radiotherapy | 1 | Participants | |
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Placebo | Censored, New Anti-cancer Agent/Radiotherapy | 1 | Participants | |
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Lapatinib 1500 mg | Censored, Follow-up Ended | 1318 | Participants | |
| Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Placebo | Censored, Follow-up Ended | 1285 | Participants | |
| Number of Participants Who Died (Overall Survival) | Lapatinib 1500 mg | Died | 115 | Participants | |
| Number of Participants Who Died (Overall Survival) | Placebo | Died | 126 | Participants | |
| Number of Participants Who Died (Overall Survival) | Lapatinib 1500 mg | Censored, Follow-up Ended | 1456 | Participants | |
| Number of Participants Who Died (Overall Survival) | Placebo | Censored, Follow-up Ended | 1450 | Participants |
1 to 10 of 488Source ClinicalTrials.gov
See all 488 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib 1500 mg | 1,579 | |
| Overall Study | STARTED | Placebo | 1,582 | |
| Overall Study | Received >=1 Dose of Study Treatment | Lapatinib 1500 mg | 1,571 | |
| Overall Study | Received >=1 Dose of Study Treatment | Placebo | 1,576 | |
| Overall Study | COMPLETED | Lapatinib 1500 mg | 322 | |
| Overall Study | COMPLETED | Placebo | 278 | |
| Overall Study | NOT COMPLETED | Lapatinib 1500 mg | 1,257 | |
| Overall Study | NOT COMPLETED | Placebo | 1,304 |
Source ClinicalTrials.gov
Adverse events332
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 | Lapatinib 1500 mg | 955 | 1,573 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 256 | 1,574 | |
| other | Rash | Skin and subcutaneous tissue disorders | Lapatinib 1500 mg | 922 | 1,573 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 243 | 1,574 | |
| other | Nausea | Gastrointestinal disorders | Lapatinib 1500 mg | 279 | 1,573 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 179 | 1,574 | |
| other | Fatigue | General disorders | Lapatinib 1500 mg | 251 | 1,573 | |
| other | Fatigue | General disorders | Placebo | 202 | 1,574 | |
| other | Headache | Nervous system disorders | Lapatinib 1500 mg | 140 | 1,573 | |
| other | Headache | Nervous system disorders | Placebo | 185 | 1,574 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib 1500 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lapatinib 1500 mg | 1,443 | 1,573 |
| Total, other adverse events | Placebo | 1,175 | 1,574 |
| Total, serious adverse events | Lapatinib 1500 mg | 99 | 1,573 |
| Total, serious adverse events | Placebo | 78 | 1,574 |
Source ClinicalTrials.gov
Papers3
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lapatinib 1500 mg vs Placebo: Number of Participants With CNS Recurrence | Trial comparisons |
| Lapatinib 1500 mg vs Placebo: Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) | Trial comparisons |
| Lapatinib 1500 mg vs Placebo: 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.
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