Clinical trial NCT02650817: Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer
Official title: A Phase IB Study to Evaluate the Effect of RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer Lesions Using 16α-18F-Fluoro-17β-Estradiol Positron Emission Tomography Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Effect of ER Binding after RAD1901 treatment
timeFrame: 14 Days after the first dose
Secondary outcomes:
measure: Correlation of FES uptake after RAD1901 treatment to clinical response
timeFrame: Every 8 weeks for to up 12 months of treatment
measure: Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines
timeFrame: Every 8 weeks for to up 12 months of treatment
measure: Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values
timeFrame: Up to 30 days after the end of treatment
measure: Plasma concentrations of RAD1901 will be assessed at predefined intervals
timeFrame: Every 28 days for up to 3 cycles
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum (VUMC)
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG)
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Universitair Medisch Centrum Groningen (UMCG)
name: Elisabeth GE de Vries, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jager A, de Vries EGE, der Houven van Oordt CWM, Neven P, Venema CM, Glaudemans AWJM, Wang Y, Bagley RG, Conlan MG, Aftimos P. A phase 1b study evaluating the effect of elacestrant treatment on estrogen receptor availability and estradiol binding to the estrogen receptor in metastatic breast cancer lesions using 18F-FES PET/CT imaging. Breast Cancer Res. 2020 Sep 11;22(1):97. doi: 10.1186/s13058-020-01333-3.