Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03975647
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2019-06-04
Brief Title:
A Study of Tucatinib vs Placebo in Combination With Ado-trastuzumab Emtansine T-DM1 for Patients With Advanced or Metastatic HER2 Breast Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
Randomized Double-blind Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine T-DM1 for Subjects With Unresectable Locally-advanced or Metastatic HER2 Breast Cancer HER2CLIMB-02
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 is being done to see if tucatinib with ado-trastuzumab emtansine T-DM1 works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma The breast cancer in this study is either metastatic spread into other parts of the body or cannot be removed completely with surgery
Patients in this study will be randomly assigned to get either tucatinib or placebo a pill with no medicine This is a blinded study so neither patients nor their doctors will know whether a patient gets tucatinib or placebo All patients in the study will get T-DM1 a drug that is often used to treat this cancer
Each treatment cycle lasts 21 days Patients will swallow tucatinib pills or placebo pills two times every day Patients will get T-DM1 injections from the study site staff on the first day of every cycle
Patients in this study will be randomly assigned to get either tucatinib or placebo a pill with no medicine This is a blinded study so neither patients nor their doctors will know whether a patient gets tucatinib or placebo All patients in the study will get T-DM1 a drug that is often used to treat this cancer
Each treatment cycle lasts 21 days Patients will swallow tucatinib pills or placebo pills two times every day Patients will get T-DM1 injections from the study site staff on the first day of every cycle
Detailed Description:
This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2 breast cancer who have had prior treatment with a taxane and trastuzumab in any setting Prior pertuzumab treatment is permitted but not required Participants will be randomized in a 11 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1
While on study treatment participants will be assessed for progression every 6 weeks for the first 24 weeks and every 9 weeks thereafter irrespective of dose holds or interruptions Study treatment will continue until unacceptable toxicity disease progression withdrawal of consent or study closure After completion of study treatment and after occurrence of disease progression participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent
While on study treatment participants will be assessed for progression every 6 weeks for the first 24 weeks and every 9 weeks thereafter irrespective of dose holds or interruptions Study treatment will continue until unacceptable toxicity disease progression withdrawal of consent or study closure After completion of study treatment and after occurrence of disease progression participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent
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