Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 6:57 PM
Study NCT ID:
NCT07198724
Status:
None
Last Update Posted:
2025-11-05 00:00:00
First Post:
2025-09-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
Status:
None
Status Verified Date:
2025-11
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:
ERADICATE
Brief Summary:
This phase Ib/II, open-label, single-arm, investigator-initiated study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy.
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational dose to use for further studies. "Investigational" means that the drug is being studied.
The phase Ib dose-escalation portion of the study is to determine the recommended phase II dose (RP2D) of the Elacestrant in combination with trastuzumab deruxtecan, followed by a phase II expansion to further evaluate efficacy and safety at the RP2D.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, electrocardiograms (ECGs), and tumor biopsies.
The U.S. Food and Drug Administration (FDA) has not approved Elacestrant for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer but it has been approved for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA has approved trastuzumab deruxtecan as a treatment option for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer.
The FDA has not approved the combination of Elacestrant and Trastuzumab deruxtecan for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer.
It is expected that about 65 people will take part in this research study.
Stemline-Menarini is supporting this research study by providing the study drug, Elacestrant.
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational dose to use for further studies. "Investigational" means that the drug is being studied.
The phase Ib dose-escalation portion of the study is to determine the recommended phase II dose (RP2D) of the Elacestrant in combination with trastuzumab deruxtecan, followed by a phase II expansion to further evaluate efficacy and safety at the RP2D.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, electrocardiograms (ECGs), and tumor biopsies.
The U.S. Food and Drug Administration (FDA) has not approved Elacestrant for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer but it has been approved for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA has approved trastuzumab deruxtecan as a treatment option for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer.
The FDA has not approved the combination of Elacestrant and Trastuzumab deruxtecan for CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer.
It is expected that about 65 people will take part in this research study.
Stemline-Menarini is supporting this research study by providing the study drug, Elacestrant.
Detailed Description:
None
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?: