Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02000596
Status:
TERMINATED
Last Update Posted:
2022-05-27
First Post:
2013-11-21
Brief Title:
1303GCC Trastuzmab Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
1303GCC Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2Neu Overexpressed Locally Advanced andor Metastatic Breast Carcinoma
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding withdrawn by sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2neu overexpressed locally advanced andor metastatic breast carcinoma
Detailed Description:
Currently available standard therapies for HER2 overexpressed metastatic breast cancers MBC include treatments with chemotherapy or hormonal therapy alone or in combination with medications that target HER2 gene such as Trastuzumab or Pertuzumab This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab without hormonal or chemotherapy as a first line treatment If patients progress on this treatment they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| GCC1303 | OTHER | University of Maryland Greenebaum Cancer Center | None |