Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533826
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd TRADE DXd
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Non-comparative Trial of Datopotamab Deruxtecan Dato-DXd or Trastuzumab Deruxtecan T-DXd in Patients With Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRADE DXd
Brief Summary:
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs trastuzumab deruxtecan followed by datopotamab deruxtecan or datopotamab deruxtecan followed by trastuzumab deruxtecan to learn whether the treatment works in treating HER2-low metastatic breast cancer
The names of the study drugs involved in this study are
Datopotamab deruxtecan a type of antibody drug conjugate
Trastuzumab deruxtecan a type of antibody drug conjugate
The names of the study drugs involved in this study are
Datopotamab deruxtecan a type of antibody drug conjugate
Trastuzumab deruxtecan a type of antibody drug conjugate
Detailed Description:
This is a multi-institutional open-label phase 2 trial assessing the efficacy of sequential antibody drug conjugate ADC treatment with Dato-DXd or T-DXd in participants with HER2-low locally advanced unresectable or metastatic breast cancer MBC
There are two parts to this study which has a sequential design Most participants will enroll in Group 1 which has two different study drugs A participant will be randomized to receive one of the two study drugs and if there is progression of disease on the study drug that was originally assigned a participant will crossover to a different arm in Group 2 and receive the other study drug Some participants may enroll directly to Group 2 if they already received the first drug The goal is to evaluate the effectiveness of sequential ADC therapy by switching the target of the ADC
Randomization means participants are placed into a treatment arm by chance Participants will be randomized into one of four treatment arms in Group 1
Arm A Trastuzumab deruxtecan in hormone receptor HR-positive metastatic breast cancer MBC
Arm B Trastuzumab deruxtecan in HR-negative MBC
Arm C Datopotamab deruxtecan in HR-positive MBC
Arm D Datopotamab deruxtecan in HR-negative MBC
Participants may crossover to one of the below treatment arms in Group 2
Arm E Datopotamab deruxtecan in HR-positive MBC
Arm F Datopotamab deruxtecan in HR-negative MBC
Arm G Trastuzumab deruxtecan in HR-positive MBC
Arm H Trastuzumab deruxtecan in HR-negative MBC
The US Food and Drug Administration FDA has not approved Datopotamab deruxtecan as a treatment for HER2-low metastatic breast cancer
The US FDA has approved Trastuzumab deruxtecan for previously treated HER2-low metastatic breast cancer and for other uses
The research study procedures include screening for eligibility study treatment visits blood tests tumor biopsies questionnaires echocardiograms electrocardiograms Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and eye exams
Participants will receive study treatment for as long as there is benefit After the study treatment ends participants will be followed approximately every six months thereafter
It is expected that about 357 people will take part in this research study
AstraZeneca is supporting this research study by providing the study drugs and funding
There are two parts to this study which has a sequential design Most participants will enroll in Group 1 which has two different study drugs A participant will be randomized to receive one of the two study drugs and if there is progression of disease on the study drug that was originally assigned a participant will crossover to a different arm in Group 2 and receive the other study drug Some participants may enroll directly to Group 2 if they already received the first drug The goal is to evaluate the effectiveness of sequential ADC therapy by switching the target of the ADC
Randomization means participants are placed into a treatment arm by chance Participants will be randomized into one of four treatment arms in Group 1
Arm A Trastuzumab deruxtecan in hormone receptor HR-positive metastatic breast cancer MBC
Arm B Trastuzumab deruxtecan in HR-negative MBC
Arm C Datopotamab deruxtecan in HR-positive MBC
Arm D Datopotamab deruxtecan in HR-negative MBC
Participants may crossover to one of the below treatment arms in Group 2
Arm E Datopotamab deruxtecan in HR-positive MBC
Arm F Datopotamab deruxtecan in HR-negative MBC
Arm G Trastuzumab deruxtecan in HR-positive MBC
Arm H Trastuzumab deruxtecan in HR-negative MBC
The US Food and Drug Administration FDA has not approved Datopotamab deruxtecan as a treatment for HER2-low metastatic breast cancer
The US FDA has approved Trastuzumab deruxtecan for previously treated HER2-low metastatic breast cancer and for other uses
The research study procedures include screening for eligibility study treatment visits blood tests tumor biopsies questionnaires echocardiograms electrocardiograms Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and eye exams
Participants will receive study treatment for as long as there is benefit After the study treatment ends participants will be followed approximately every six months thereafter
It is expected that about 357 people will take part in this research study
AstraZeneca is supporting this research study by providing the study drugs and funding
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