Actively Recruiting
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
Led by Sarah Sammons, MD · Updated on 2026-04-09
65
Participants Needed
1
Research Sites
654 weeks
Total Duration
On this page
Sponsors
S
Sarah Sammons, MD
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this 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. The names of the study drugs involved in this study are: * Elacestrant (a type of selective estrogen receptor degrader) * Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HR+/HER2-low or HER2-ultralow metastatic or unresectable locally advanced breast cancer confirmed by pathology or cytology
- Prior treatment with CDK4/6 inhibitor plus endocrine therapy with disease progression as specified
- Measurable disease according to RECIST 1.1 criteria
- Known ESR1 mutation status within 6 months before enrollment
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function as defined by laboratory values
- Stable or untreated asymptomatic brain metastases allowed under specified conditions
- Women must be postmenopausal or premenopausal on GnRH agonist therapy
- Negative pregnancy test for premenopausal women
- Agreement to use effective contraception during the study and for specified periods after
- Ability to swallow and retain oral medication
- Willingness to undergo two mandatory tumor biopsies
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with antibody-drug conjugates in any setting
- Prior treatment with novel oral estrogen receptor degraders or modulators in metastatic setting (except fulvestrant)
- Symptomatic brain metastases or those requiring therapy for symptom control
- Neurosurgical resection or brain biopsy within 4 weeks before study start
- Use of other investigational drugs or devices within 2 weeks before study start
- History of allergic reactions to elacestrant or trastuzumab deruxtecan
- History of pneumonitis requiring steroids or current interstitial lung disease
- Pregnant, breastfeeding, or planning pregnancy during study and follow-up periods
- Active tuberculosis infection
- Uncontrolled illnesses including infections, serious cardiovascular disease, uncontrolled diabetes, gastrointestinal disorders affecting drug absorption, or psychiatric conditions limiting compliance
- Active hepatitis B or C infection
- History of other malignancies unless disease-free for at least 3 years or certain low-risk cancers treated within 5 years
- Significant cardiovascular disease such as recent heart attack, unstable angina, or congestive heart failure NYHA Class II-IV
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Sarah Sammons, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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