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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Kristina A. Fanucci
Study ID
NCT07198724
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    Selective estrogen receptor degrader (SERD), film-coated tablet, taken orally per protocol.
  • Trastuzumab Deruxtecan — DRUG
    HER2-directed antibody-drug conjugate, vial, via intravenous (into the vein) infusion per standard of care

Study Details

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)

Key Dates

Start date
Nov 17, 2025
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2038

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Elacestrant + Trastuzumab Deruxtecan
    Up to 28 participants will be enrolled to determine the recommended phase 2 dosage of Elacestrant and will complete the following: * Baseline visit * Cycle 1 (21 day cycle) * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * Cycle 2 through End of Treatment (21 day cycle): * Imaging every 9 weeks until Cycle 9, then every 12 weeks * Day 1: tumor biopsy * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * End of Treatment visit with imaging * Follow up visits every 6 months * If 3 or less out of 12 participants experience a dose-limiting toxicity (DLT), the recommended Phase II dose of Elacestrant will be that dose level. If there are 4 or more DLTs, Elacestrant dosage will de-escalate and 12 more participants will be enrolled.
  • Experimental: Phase 2: Elacestrant + Trastuzumab Deruxtecan
    37 participants will complete the following: * Baseline visit -Cycle 1 (21 day cycle) * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. -Cycle 2 through End of Treatment (21 day cycle): * Imaging every 9 weeks until Cycle 9, then every 12 weeks * Day 1: tumor biopsy * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * End of Treatment visit with imaging * Follow up visits every 6 months

Primary Outcome Measure

Recommended phase II dose (RP2D) [ Time Frame: Assessed at the end of the first treatment cycle, Day 21. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kristina Fanucci, MD
[email protected]
617-362-3800
Kristina Fanucci, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MA

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