Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490139
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2007-06-20
Brief Title:
ALTTO Adjuvant Lapatinib AndOr Trastuzumab Treatment Optimisation Study BIG 2-06N063D
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomised Multi-centre Open-label Phase III Study of Adjuvant Lapatinib Trastuzumab Their Sequence and Their Combination in Patients With HER2ErbB2 Positive Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTTO
Brief Summary:
This is a randomised open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing andor amplified breast cancer Patients will be enrolled according to one of two design schemas with Design 2 having two chemotherapy options Design 2 and 2B and will be randomised to one of four treatment regimens within each design schema
The primary objective of this study is to compare disease-free survival DFS in patients with HER2 overexpressing andor amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab 12 or 18 weeks according to assigned design followed by a six-week treatment-free interval followed by lapatinib 28 or 34 weeks according to assigned design versus trastuzumab in combination with lapatinib for one year 52 weeks Secondary objectives include treatment comparisons with respect to overall survival time to recurrence time to distant recurrence safety and tolerability incidence of brain metastasis and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification expression level of PTEN and presence or absence of the p95HER2 receptor On August 18 2011 the ALTTO Independent Data Monitoring Committee IDMC met to review the first planned interim analysis The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival DFS The IDMC also stated that the other three arms trastuzumab alone sequential trastuzumablapatinib arm and the combination arm should continue as planned with no changes
The primary objective of this study is to compare disease-free survival DFS in patients with HER2 overexpressing andor amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab 12 or 18 weeks according to assigned design followed by a six-week treatment-free interval followed by lapatinib 28 or 34 weeks according to assigned design versus trastuzumab in combination with lapatinib for one year 52 weeks Secondary objectives include treatment comparisons with respect to overall survival time to recurrence time to distant recurrence safety and tolerability incidence of brain metastasis and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification expression level of PTEN and presence or absence of the p95HER2 receptor On August 18 2011 the ALTTO Independent Data Monitoring Committee IDMC met to review the first planned interim analysis The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival DFS The IDMC also stated that the other three arms trastuzumab alone sequential trastuzumablapatinib arm and the combination arm should continue as planned with no changes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-000562-36 | EUDRACT_NUMBER | Novartis | None |
| CLAP016B2301 | OTHER | None | None |