Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272987
Status:
TERMINATED
Last Update Posted:
2023-04-28
First Post:
2006-01-04
Brief Title:
ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel Trastuzumab and Lapatinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Multicenter Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women With ErbB2 Overexpressing Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was closed after the open label stage due to poor recruitment rate randomized stage never opened
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was originally designed as a Phase III randomized double blind placebo controlled study to assess the safety and tolerability and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel trastuzumab and lapatinib Following poor recruitment rate in the open label stage the randomized stage of the study was terminated thus no subjects were enrolled into the randomization stage
Detailed Description:
The primary objective of this study was to evaluate and compare time to progression TTP The Primary objective for open label phase was to determine the safety and tolerability of lapatinib when administered in combination with both paclitaxel and trastuzumab The study first enrolled an open label safety cohort of 20 patients to assess the tolerability of the triplet combination This was a 1 arm 3 cohort study stage
Open-label Phase Patients were sequentially enrolled into three cohorts and received an open-label combination of paclitaxel trastuzumab and lapatinib Cohort 1 received paclitaxel 80mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 1000 mg PO daily Cohort 2 received paclitaxel 70mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 1000 mg PO daily Cohort 3 paclitaxel 80mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 750 mg PO daily
Randomized Phase was terminated following the poor recruitment rate in the open-label safety stage No subjects were enrolled into the randomization stage
In summary at approximately 35 years the primary analysis which included demographics efficacy and safety were conducted at approximately 7 years protocol amendment 7 cancelled collection of efficacy endpoints and only key safety endpoints were to be collected the final analysis was performed at approximately 14 years
Open-label Phase Patients were sequentially enrolled into three cohorts and received an open-label combination of paclitaxel trastuzumab and lapatinib Cohort 1 received paclitaxel 80mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 1000 mg PO daily Cohort 2 received paclitaxel 70mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 1000 mg PO daily Cohort 3 paclitaxel 80mgm2 IV weekly for 3 weeks of a 4 week cycle trastuzumab 4 mgkg IV loading dose and 2 mgkg IV weekly and lapatinib 750 mg PO daily
Randomized Phase was terminated following the poor recruitment rate in the open-label safety stage No subjects were enrolled into the randomization stage
In summary at approximately 35 years the primary analysis which included demographics efficacy and safety were conducted at approximately 7 years protocol amendment 7 cancelled collection of efficacy endpoints and only key safety endpoints were to be collected the final analysis was performed at approximately 14 years
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 |
|---|---|---|---|
| CLAP016A2301 | OTHER | Novartis | None |
| 2005-003432-22 | EUDRACT_NUMBER | None | None |