ERADICATE: Hormone and Targeted Therapy for HR+/HER2-Low Advanced Breast Cancer
Treatment
Phase Ib/II study of hormone and targeted therapy for advanced breast cancer
Clinicaltrials.gov identifier:NCT07198724
Study Contact Information:
Kristina Fanucci, MD
Phone: 617-362-3800
Email: [email protected]
About the Study
This study is looking at the safety and effectiveness of elacestrant, a hormone therapy that blocks receptors to help prevent cancer cells from growing, in combination with trastuzumab deruxtecan (T-DXd), a targeted treatment that combines an antibody directed at with a chemotherapy drug. The study is for people with hormone receptor-positive (HR+), HER2-low or HER2-ultralow breast cancer that has spread to other parts of the body () or is locally advanced and cannot be removed with surgery. Participants must have cancer that has progressed despite treatment with a CDK4/6 inhibitor and hormone therapy.
This Study is Open To:
- People aged 18 or older.
- People with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that is or locally advanced and cannot be removed with surgery.
- People who have previously received a CDK4/6 inhibitor and hormone therapy for breast cancer.
- People who have received up to one prior line of chemotherapy or an antibody-drug conjugate for disease.
- People whose ESR1 mutation status is known from tumor testing or a blood-based tumor test.
- People whose cancer can be measured on imaging tests.
- People who are able to take medication by mouth and meet the study's other health and safety requirements.
This Study is NOT Open To:
- Have previously received a topoisomerase inhibitor antibody-drug conjugate.
- Have received certain oral receptor-targeting medications for breast cancer, such as elacestrant-like drugs in the SERD, SERM, PROTAC, or CERAN categories. Prior treatment with fulvestrant is allowed.
- Have brain metastases that are causing symptoms or require immediate treatment. Some people with stable or symptom-free brain metastases may be eligible.
- Have had a serious allergic reaction to drugs similar to either study drug.
- Have received another investigational drug or device within two weeks before starting this study.
- Have certain lung conditions, including a history of noninfectious pneumonitis that required steroid treatment or current interstitial lung disease.
- Are pregnant or breastfeeding.
- Have certain uncontrolled medical conditions or another cancer history that does not meet the study's eligibility requirements.
What the study Involves
This is a Phase Ib/II clinical trial.
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Phase Ib: Researchers will evaluate the safety and side effects of the drug combination and determine the recommended dose for the next phase.
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Phase II: Researchers will further evaluate how well the combination works and its safety at the recommended dose.
Participants will receive elacestrant in combination with trastuzumab deruxtecan. The study involves medical assessments and tests to monitor participants' health, side effects, and response to treatment. The research team will provide details about the treatment schedule and required tests.
Study Contact Information:
Kristina Fanucci, MD
Phone: 617-362-3800
Email: [email protected]
Locations:
Massachusetts
City: Boston RECRUITING
Facility: Dana-Farber Cancer Institute
Contact Info:
[email protected]
617-362-3800
Kristina Fanucci, MD
Treatment
Phase Ib/II study of hormone and targeted therapy for advanced breast cancer
Clinicaltrials.gov identifier:NCT07198724
Study Contact Information:
Kristina Fanucci, MD
Phone: 617-362-3800
Email: [email protected]