Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT02491892
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2
Status:
COMPLETED
Status Verified Date:
2015-08
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 study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: