Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281658
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2006-01-23
Brief Title:
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Multicenter Double-Blind Placebo-Controlled Phase III Study of Lapatinib GW572016 in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-02
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:
None
Brief Summary:
This was a randomized double-blind placebo-controlled multicenter Phase III study to evaluate and compare the efficacy and safety of Lapatinib Paclitaxel versus Placebo Paclitaxel in men and women with ErbB2 amplified metastatic Stage IV breast cancer who had not received prior therapy for metastatic disease
Detailed Description:
Subjects were randomized to receive either Lapatinib 1500 mg once daily Paclitaxel 80 mgm2 IV weekly for 3 weeks every 4 weeks or Placebo once daily Paclitaxel 80 mgm2 IV weekly for 3 weeks every 4 weeks
Subjects who progressed while on study and were on the placebopaclitaxel arm were permitted to enter an extension phase of open label monotherapy therapy with lapatinib or open label combination therapy with lapatinibpaclitaxel and followed for response progression and survival
Based on the positive results in the primary analysis Protocol Amendment 02 dated 09 May 2011 discontinued further entry into the lapatinib monotherapy extension phase and ongoing subjects taking placebo were permitted to replace it with open label lapatinib therapy with or without continued paclitaxel therapy
Following the primary Overall Survival OS analysis and subsequent implementation of Protocol Amendment 03 subjects who were still receiving active treatment entered the Long-term follow-up LTFU phase of the study Reporting requirements in the LTFU phase were limited to Adverse events of special interest AESI Serious adverse events SAEs and pregnancy and the subjects continued to receive treatment until the occurrence of unacceptable toxicity or disease progression as determined by the investigator or permanent withdrawal from treatment for any reason Subjects who were no longer receiving active treatment were withdrawn from the study
Subjects who progressed while on study and were on the placebopaclitaxel arm were permitted to enter an extension phase of open label monotherapy therapy with lapatinib or open label combination therapy with lapatinibpaclitaxel and followed for response progression and survival
Based on the positive results in the primary analysis Protocol Amendment 02 dated 09 May 2011 discontinued further entry into the lapatinib monotherapy extension phase and ongoing subjects taking placebo were permitted to replace it with open label lapatinib therapy with or without continued paclitaxel therapy
Following the primary Overall Survival OS analysis and subsequent implementation of Protocol Amendment 03 subjects who were still receiving active treatment entered the Long-term follow-up LTFU phase of the study Reporting requirements in the LTFU phase were limited to Adverse events of special interest AESI Serious adverse events SAEs and pregnancy and the subjects continued to receive treatment until the occurrence of unacceptable toxicity or disease progression as determined by the investigator or permanent withdrawal from treatment for any reason Subjects who were no longer receiving active treatment were withdrawn from the study
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 |
|---|---|---|---|
| CLAP016A2302 | OTHER | Novartis | None |