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A Phase 1b Trial of ARV-471 in Combination with Everolimus in Patients with ER+, HER2– Advanced or Metastatic Breast Cancer
EU CTIS ID: 2024-513284-30-00
What this study is testing
Evaluate the safety and tolerability of ARV-471 in combination with everolimus and select the RP2D for the combination.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be ≥ 18 years.
- Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer (metastatic, recurrent, or unresectable). • ER+ disease must be documented by IHC according to the ASCO/CAP Guidelines • HER2- disease must be documented by either IHC or in situ hybridization per ASCO/CAP guidelines
- Women must meet definitions below for one of the following categories: Postmenopausal women must have at least 1 of the following: prior bilateral oophorectomy, age ≥ 60 years, or age < 60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH/estradiol in the postmenopausal range • Pre- and peri-menopausal women must be on ovarian suppression with a GnRH agonist for at least 4 weeks prior to initiation of study treatment and for 8 weeks after the last dose of study treatment.
- Patients must have measurable disease or non-measurable (evaluable) disease, per RECIST 1.1.
- ECOG (Eastern Cooperative Group) performance status of 0 or 1.
- Patients must have received a minimum of 1 and up to 3 lines of anticancer therapy in the advanced/metastatic setting: • Patients must have received and progressed on (or were intolerant to) a CDK 4/6 inhibitor, either alone or in combination • Patients must have received at least 1 endocrine therapy, either alone or in combination • Patients may have received up to 1 line of chemotherapy
You likely can't join if
- Untreated brain metastases or brain metastases requiring steroids above physiologic replacement doses
- Any of the following in the previous 12 months: • Myocardial infarction • Severe/unstable angina • Coronary/peripheral artery bypass graft • Symptomatic (NYHA class III or IV) congestive heart failure • Cerebrovascular accident (CVA) • Transient ischemic attack (TIA) • Symptomatic pulmonary embolism • Other clinically significant episode of thromboembolism
- Any of the following in the previous 6 months: • Congenital long QT syndrome • Torsade de Pointes, • Sustained ventricular tachyarrhythmia and ventricular fibrillation • Left anterior hemiblock (bifascicular block) • Ongoing cardiac arrythmias/dysrhythmias of NCI CTCAE Grade ≥2 • Atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation)
- Patients with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung function.
- Prior treatment with ARV-471.
- Prior treatment(s) (including investigational treatments) targeting mTOR (e. g. everolimus).
See the full eligibility criteria
Who can join
- Patients must be ≥ 18 years.
- Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer (metastatic, recurrent, or unresectable). • ER+ disease must be documented by IHC according to the ASCO/CAP Guidelines • HER2- disease must be documented by either IHC or in situ hybridization per ASCO/CAP guidelines
- Women must meet definitions below for one of the following categories: Postmenopausal women must have at least 1 of the following: prior bilateral oophorectomy, age ≥ 60 years, or age < 60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH/estradiol in the postmenopausal range • Pre- and peri-menopausal women must be on ovarian suppression with a GnRH agonist for at least 4 weeks prior to initiation of study treatment and for 8 weeks after the last dose of study treatment.
- Patients must have measurable disease or non-measurable (evaluable) disease, per RECIST 1.1.
- ECOG (Eastern Cooperative Group) performance status of 0 or 1.
- Patients must have received a minimum of 1 and up to 3 lines of anticancer therapy in the advanced/metastatic setting: • Patients must have received and progressed on (or were intolerant to) a CDK 4/6 inhibitor, either alone or in combination • Patients must have received at least 1 endocrine therapy, either alone or in combination • Patients may have received up to 1 line of chemotherapy
- Must be willing and capable of taking oral medication without crushing, dissolving, or chewing tablets/capsules.
What rules you out
- Untreated brain metastases or brain metastases requiring steroids above physiologic replacement doses
- Any of the following in the previous 12 months: • Myocardial infarction • Severe/unstable angina • Coronary/peripheral artery bypass graft • Symptomatic (NYHA class III or IV) congestive heart failure • Cerebrovascular accident (CVA) • Transient ischemic attack (TIA) • Symptomatic pulmonary embolism • Other clinically significant episode of thromboembolism
- Any of the following in the previous 6 months: • Congenital long QT syndrome • Torsade de Pointes, • Sustained ventricular tachyarrhythmia and ventricular fibrillation • Left anterior hemiblock (bifascicular block) • Ongoing cardiac arrythmias/dysrhythmias of NCI CTCAE Grade ≥2 • Atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation)
- Patients with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung function.
- Prior treatment with ARV-471.
- Prior treatment(s) (including investigational treatments) targeting mTOR (e. g. everolimus).
- Prior anticancer or investigational drug treatment within the following windows: • Fulvestrant treatment < 28 days before C1D1 • Tamoxifen or AI < 14 days before C1D1 • CDK 4/6 treatment < 14 days before C1D1
- Any prior anticancer or investigational anticancer drug therapy < 28 days or five half-lives (whichever is shorter) before C1D1 (except as mentioned in exclusion criteria above).
- Any live vaccines within 14 days of C1D1.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.