Metastatic Breast Cancer
Conditions
Brief summary
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)
Detailed description
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) using 16α-18F-Fluoro-17β-estradiol (FES) positron emission tomography (PET) imaging
Interventions
DRUGRAD1901
RAD1901, a novel selective ER degrader (SERD)
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC 2. Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting 3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease 4. Greater than or equal to 18 years of age 5. Patients must be post-menopausal 6. Life expectancy \>3 months Key
Exclusion criteria
1. Greater than 3 lines of endocrine therapy for metastatic disease. 2. Prior anti-cancer treatment or investigational drug therapy within the following windows: 1. Tamoxifen or fulvestrant therapy \< 42 days before 1st 18FES-PET scan 2. Any other anti-cancer endocrine therapy \< 14 days before 1st dose of study drug 3. Any chemotherapy \< 28 days before 1st dose of study drug 4. Any investigational drug therapy \< 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. Patients with untreated or symptomatic central nervous system (brain) metastases 3. Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ER Binding after RAD1901 treatment | 14 Days after the first dose | To determine the effect of RAD1901 treatment on the estrogen receptor (ER) expression and estradiol binding to the ER in lesions from patients with metastatic breast cancer (mBC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of FES uptake after RAD1901 treatment to clinical response | Every 8 weeks for to up 12 months of treatment | To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response |
| Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines | Every 8 weeks for to up 12 months of treatment | To determine if there is a tumor response to RAD1901 treatment |
| Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values | Up to 30 days after the end of treatment | Characterization of the safety of RAD1901 in this patient population |
| Plasma concentrations of RAD1901 will be assessed at predefined intervals | Every 28 days for up to 3 cycles | Pharmacokinetic data will be collected. |
Countries
Belgium, Netherlands
Outcome results
None listed