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New treatment option for Metastatic Breast Cancer
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
ClinicalTrials.gov ID: NCT07198724
What this study is testing
What is Elacestrant?
Elacestrant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic breast cancer.
Also referred to as Elacestrant dihydrochloride, RAD1901.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have a histologically or cytologically confirmed diagnosis of HR+/HER2-low metastatic or unresectable locally advanced breast...
- Participants must have had prior CDK4/6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.
- Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.
- Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have...
- Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360...
You likely can't join if
- Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.
- Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior...
- Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or...
- Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.
- History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.
See the full eligibility criteria
Who can join
- Participants must have a histologically or cytologically confirmed diagnosis of HR+/HER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in the most recent sample and HER2-low...
- Participants must have had prior CDK4/6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.
- Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.
- Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have measurable disease, defined as at least one lesion that can be...
- Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360 CDx testing for ESR1-mutation status if status has not been validated...
- Women or men age ≥18 years are eligible.
- ECOG performance status ≤ 2.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2 x ULN in patients with documented Gilbert's syndrome)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional ULN (or \< 5 x ULN in patients with liver metastases)
- Creatinine ≤ 1.5 x institutional ULN OR
- Calculated creatinine clearance ≥ 45 mL/min via the Cockcroft-Gault formula for participants with creatinine levels above institutional ULN
- Baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).
- Participants with a history of central nervous system (CNS) metastases are eligible if: Stable or untreated, asymptomatic brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \>...
- Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment...
- Patients treated with CNS local therapy for newly identified lesions may be eligible to enroll if all of the following criteria are met: Time since WBRT is ≥ 14 days prior to first dose of treatment, time since SRS is ≥...
- Postmenopausal women must be postmenopausal, which is defined as any of the following:
- Age ≥ 60 years
- Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range
- Premenopausal women made postmenopausal through the use GnRH agonist prior to study entry are eligible and MUST remain on the GnRH agonist for the duration of protocol treatment.
- Status-post bilateral oophorectomy - After adequate healing post-surgery
- Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are postmenopausal according to the definition in 3.1.10.
- Women of child-bearing potential and men must agree to use adequate contraception at time of enrollment and for 4 months after the last dose of elacestrant or 7 months after the last dose of trastuzumab deruxtecan...
- Participants must be able to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.
- Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior fulvestrant is allowed. A washout period of 7 days is required for any endocrine...
- Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or asymptomatic brain metastases are allowed. Participants with CNS metastases...
- Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.
- History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.
- Patients who are pregnant or breastfeeding, or who expect to become pregnant within the projected duration of the study.
- Patients with active tuberculosis.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident/stroke (\< 6...
- Patients with a history of different malignancy are ineligible, except for those who have been disease-free for at least three years and are deemed by the investigator to be at low risk for recurrence of the prior...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.