Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03587740
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2018-06-21
Brief Title:
ATOP TRIAL T-DM1 in HER2 Positive Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
ATOP TRIAL Adjuvant Ado-Trastuzumab Emtansine T-DM1 for Older Patients with Human Epidermal Growth Factor Receptor 2 HER2-Positive Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2 also known as HER2-positive breast cancer
The drug involved in this study is
-ado-trastuzumab emtansine T-DM1
The drug involved in this study is
-ado-trastuzumab emtansine T-DM1
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied and research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause
The purpose of this research study is to examine the long-term benefits of T-DM1 with regard to breast cancer and take a closer look at the side effects experienced by participants receiving T-DM1
The FDA the US Food and Drug Administration has not approved T-DM1 for use in patients with stage I II or III breast cancer but it has been approved for use in advanced previously treated HER2-positive breast cancer
T-DM1 is an antibody-drug conjugate it is made up of an antibody trastuzumab linked to a cytotoxic drug DM1 chemotherapy T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly limiting exposure of the rest of the body to chemotherapy More specifically the trastuzumab in T-DM1 first binds to the HER2 protein on the surface of the breast cancer cells and the DM1 then enters the cells and can cause them to die preventing tumor growth
The purpose of this research study is to examine the long-term benefits of T-DM1 with regard to breast cancer and take a closer look at the side effects experienced by participants receiving T-DM1
The FDA the US Food and Drug Administration has not approved T-DM1 for use in patients with stage I II or III breast cancer but it has been approved for use in advanced previously treated HER2-positive breast cancer
T-DM1 is an antibody-drug conjugate it is made up of an antibody trastuzumab linked to a cytotoxic drug DM1 chemotherapy T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly limiting exposure of the rest of the body to chemotherapy More specifically the trastuzumab in T-DM1 first binds to the HER2 protein on the surface of the breast cancer cells and the DM1 then enters the cells and can cause them to die preventing tumor growth
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