Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585969
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK46 Inhibitors in Non-luminal A ER-positiveHER2-low Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK46 Inhibitors in Non-luminal A ER-positiveHER2-low Metastatic Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
DISCORDANT
Brief Summary:
The objective of this trial DBCG R25 will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival PFS in first-line for patients with non-Luminal A ER-positiveHER2-negative metastatic breast cancer
Detailed Description:
Study design and setting We will conduct an international multicentre open-label randomised controlled trial All oncological departments who treat patients with metastatic breast cancer can participate The EU Clinical Trial Regulation will be applied
Interventions Trial participants will be randomised to trastuzumab deruxtecan or standard treatment
Trastuzumab deruxtecan
Patients randomised to trastuzumab deruxtecan will be treated as
Trastuzumab deruxtecan until progression or intolerable toxicity Trastuzumab deruxtecan 54 mgkg intravenous on day 1 of a 21 days cycle
Standard
Patients randomised to standard will be treated as
CDK46 inhibitor with an endocrine therapy until progression or intolerable toxicity CDK46 inhibitor Physicians choice of ribociclib 600mg daily for 21 days in a 28 days cycle or abemaciclib 150mg twice daily
Endocrine therapy letrozole 25mg daily anastrozole 1mg daily exemestane 25mg daily tamoxifen 20mg daily or fulvestrant intramuscular 500mg every 4 weeks
Other treatment Prophylactic antiemetics are allowed including corticosteroids Prophylactic antibiotics are allowed if deemed necessary for the patient G-CSF is allowed when needed
All other symptomatic treatment to perform best of care is allowed as long as name administration and length is documented in the chart Bone targeted agents are allowed No other antineoplastic treatment is allowed
Radiological evaluation Patients will initially be scanned every 9-12 weeks as per investigators or co-investigators discretion with minimum a CT of the thorax and abdomen or a FDG-PETCT Patients with response can have this interval extended Upon progression treatmentcontrol is to be done according to department preferences but subsequent treatment and day of death must be registered
Interventions Trial participants will be randomised to trastuzumab deruxtecan or standard treatment
Trastuzumab deruxtecan
Patients randomised to trastuzumab deruxtecan will be treated as
Trastuzumab deruxtecan until progression or intolerable toxicity Trastuzumab deruxtecan 54 mgkg intravenous on day 1 of a 21 days cycle
Standard
Patients randomised to standard will be treated as
CDK46 inhibitor with an endocrine therapy until progression or intolerable toxicity CDK46 inhibitor Physicians choice of ribociclib 600mg daily for 21 days in a 28 days cycle or abemaciclib 150mg twice daily
Endocrine therapy letrozole 25mg daily anastrozole 1mg daily exemestane 25mg daily tamoxifen 20mg daily or fulvestrant intramuscular 500mg every 4 weeks
Other treatment Prophylactic antiemetics are allowed including corticosteroids Prophylactic antibiotics are allowed if deemed necessary for the patient G-CSF is allowed when needed
All other symptomatic treatment to perform best of care is allowed as long as name administration and length is documented in the chart Bone targeted agents are allowed No other antineoplastic treatment is allowed
Radiological evaluation Patients will initially be scanned every 9-12 weeks as per investigators or co-investigators discretion with minimum a CT of the thorax and abdomen or a FDG-PETCT Patients with response can have this interval extended Upon progression treatmentcontrol is to be done according to department preferences but subsequent treatment and day of death must be registered
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