Trial · NCT00490139
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
NCT00490139, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-08-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D. Trials, record NCT00490139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00490139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
- NCT number
- NCT00490139
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8,381 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Neoplasms, Breast
- Interventions
- Lapatinib, Trastuzumab
- First posted
- 2007-06-22
- Last updated
- 2025-03-21
- Other registries' IDs
- eudract:2006-000562-36
- Results first posted
- 2014-08-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival (DFS) at the Primary Analysis | From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years) | Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence. DFS was estimated using the Kaplan Meier method. The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years. |
| Secondary | Disease-Free Survival (DFS) at the 10-Year Follow-Up | From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years | Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence. DFS was estimated using the Kaplan Meier method. The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who had disease free survival for the indicated years. |
| Secondary | Overall Survival (OS) at the Primary Analysis | From randomization until death due to any cause (median follow-up of 4.5 years) | Overall Survival (OS) was defined as the time from randomization until death due to any cause. Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent. OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years. |
| Secondary | Overall Survival (OS) at the 10-Year Follow-Up | From randomization until death due to any cause, assessed up to approximately 10 years | Overall Survival (OS) was defined as the time from randomization until death due to any cause. Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent. OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 95 and 90 percent) of participants who survived for the indicated years. |
| Secondary | Analysis of Time to Recurrence (TTR) | From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years | Time to Recurrence (TTR) was defined as the the time from randomization to breast cancer recurrence, ignoring second primary cancers (including contralateral breast cancers and non-breast second malignancies) and counting deaths without recurrence as a competing risk. |
| Secondary | Analysis of Time to Distant Recurrence (TTDR) | From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years | Time to Distant Recurrence (TTDR) was defined as the the time from randomization to first distant breast cancer recurrence, ignoring locoregional recurrences and second primary cancers, (including contralateral breast cancers and non-breast second malignancies ) and counting deaths without recurrence as a competing risk. |
| Secondary | Analysis of Time to Central Nervous System (CNS) Recurrence | From randomization until the first central nervous system recurrence, assessed up to approximately 10 years | Time to Central Nervous System (CNS) recurrence was defined as the time from randomization to first CNS recurrence. Both brain metastasis and meningitis carcinomatosa were considered. |
| Secondary | Cumulative Incidence of Brain Metastases | From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years | The cumulative incidence of brain metastases as the first site of breast cancer recurrence among treatment arms was assessed using a hierarchy of primary type and location of first DFS event in cases where more than one event was identified simultaneously. Because diagnostic procedures for different types of recurrence could not be performed on exactly the same day, any diagnoses noted within a two month (60 day) period of the first reported event was considered as identified simultaneously for purposes of defining the type of the first event and the date of event was be regarded as the earliest of the relevant events. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-Free Survival (DFS) at the Primary Analysis | From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years) | Intent-to-Treat (ITT) Population. DFS data for the Lapatinib alone arm include date collected up to the first interim analysis (data cut-off 11th July 2011), as the Lapatinib arm was discontinued prior to the primary analysis due to futility. All the other arms include data up to median follow-up of 4.5 years. | Years | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) at the 10-Year Follow-Up | From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Years | NUMBER |
| SECONDARY | Overall Survival (OS) at the Primary Analysis | From randomization until death due to any cause (median follow-up of 4.5 years) | Intent-to-Treat (ITT) Population. Zero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab). | Years | NUMBER |
| SECONDARY | Overall Survival (OS) at the 10-Year Follow-Up | From randomization until death due to any cause, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Years | NUMBER |
| SECONDARY | Analysis of Time to Recurrence (TTR) | From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Analysis of Time to Distant Recurrence (TTDR) | From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Analysis of Time to Central Nervous System (CNS) Recurrence | From randomization until the first central nervous system recurrence, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Brain Metastases | From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years | Intent-to-Treat (ITT) Population. The Lapatinib alone arm was discontinued prior to primary analysis due to futility. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | All Collected Deaths | Pre-treatment deaths: Up to 14 days prior to treatment. On-treatment deaths: Up to 56 weeks. Post-treatment deaths: up to 10 years. | Intent-to-Treat (ITT) Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-Free Survival (DFS) at the Primary Analysis | Lapatinib Plus Trastuzumab | 95th Percentile | 1.9 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Trastuzumab Followed by Lapatinib | 95th Percentile | 1.3 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Lapatinib | 95th Percentile | 1.0 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Trastuzumab | 95th Percentile | 1.5 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Lapatinib Plus Trastuzumab | 90th Percentile | 3.2 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Trastuzumab Followed by Lapatinib | 90th Percentile | 2.8 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Lapatinib | 90th Percentile | 1.8 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Trastuzumab | 90th Percentile | 2.6 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Lapatinib Plus Trastuzumab | 85th Percentile | 5.1 | Years | |
| Disease-Free Survival (DFS) at the Primary Analysis | Trastuzumab Followed by Lapatinib | 85th Percentile | 4.8 | Years |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib Plus Trastuzumab | 2,093 | |
| Overall Study | STARTED | Trastuzumab Followed by Lapatinib | 2,091 | |
| Overall Study | STARTED | Lapatinib | 2,100 | |
| Overall Study | STARTED | Trastuzumab | 2,097 | |
| Overall Study | Safety Population | Lapatinib Plus Trastuzumab | 2,061 | |
| Overall Study | Safety Population | Trastuzumab Followed by Lapatinib | 2,076 | |
| Overall Study | Safety Population | Lapatinib | 2,056 | |
| Overall Study | Safety Population | Trastuzumab | 2,076 | |
| Overall Study | COMPLETED | Lapatinib Plus Trastuzumab | 1,132 | |
| Overall Study | COMPLETED | Trastuzumab Followed by Lapatinib | 1,184 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events4,240
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 | Lapatinib Plus Trastuzumab | 226 | 2,061 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab Followed by Lapatinib | 168 | 2,076 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Lapatinib | 169 | 2,056 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab | 223 | 2,076 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Lapatinib Plus Trastuzumab (Post-Treatment) | 0 | ||
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab Followed by Lapatinib (Post-Treatment) | 0 | ||
| other | ANAEMIA | Blood and lymphatic system disorders | Lapatinib (Post-Treatment) | 0 | ||
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab (Post-Treatment) | 0 | ||
| other | LEUKOPENIA | Blood and lymphatic system disorders | Lapatinib Plus Trastuzumab | 174 | 2,061 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Trastuzumab Followed by Lapatinib | 138 | 2,076 |
1 to 10 of 4,240Source ClinicalTrials.gov
See all 4,240 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib Plus Trastuzumab | 7 | 2,093 |
| Total, all-cause mortality | Trastuzumab Followed by Lapatinib | 7 | 2,091 |
| Total, all-cause mortality | Lapatinib | 13 | 2,100 |
| Total, all-cause mortality | Trastuzumab | 5 | 2,097 |
| Total, all-cause mortality | Lapatinib Plus Trastuzumab (Post-Treatment) | 189 | 2,055 |
| Total, all-cause mortality | Trastuzumab Followed by Lapatinib (Post-Treatment) | 190 | 2,071 |
| Total, all-cause mortality | Lapatinib (Post-Treatment) | 250 | 2,044 |
| Total, all-cause mortality | Trastuzumab (Post-Treatment) | 228 | 2,073 |
| Total, other adverse events | Lapatinib Plus Trastuzumab | 1,930 | 2,061 |
| Total, other adverse events | Trastuzumab Followed by Lapatinib | 1,862 | 2,076 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers8
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00490139
GET https://conductscience.org/api/trials/v1/NCT00490139/results?page=2