search
Back to results

Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RAD1901
Sponsored by
Stemline Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • UZ Leuven Campus Gasthuisberg
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Universitair Medisch Centrum Groningen (UMCG)
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elacestrant (formerly RAD1901)

Arm Description

To receive daily oral elacestrant

Outcomes

Primary Outcome Measures

Effect of ER Binding after RAD1901 treatment
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 Outcome Measures

Correlation of FES uptake after RAD1901 treatment to clinical response
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
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
Characterization of the safety of RAD1901 in this patient population
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Pharmacokinetic data will be collected.

Full Information

First Posted
January 6, 2016
Last Updated
August 16, 2022
Sponsor
Stemline Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02650817
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemline Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elacestrant (formerly RAD1901)
Arm Type
Experimental
Arm Description
To receive daily oral elacestrant
Intervention Type
Drug
Intervention Name(s)
RAD1901
Other Intervention Name(s)
Elacestrant
Intervention Description
RAD1901, a novel selective ER degrader (SERD)
Primary Outcome Measure Information:
Title
Effect of ER Binding after RAD1901 treatment
Description
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)
Time Frame
14 Days after the first dose
Secondary Outcome Measure Information:
Title
Correlation of FES uptake after RAD1901 treatment to clinical response
Description
To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response
Time Frame
Every 8 weeks for to up 12 months of treatment
Title
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines
Description
To determine if there is a tumor response to RAD1901 treatment
Time Frame
Every 8 weeks for to up 12 months of treatment
Title
Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values
Description
Characterization of the safety of RAD1901 in this patient population
Time Frame
Up to 30 days after the end of treatment
Title
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Description
Pharmacokinetic data will be collected.
Time Frame
Every 28 days for up to 3 cycles

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease Greater than or equal to 18 years of age Patients must be post-menopausal Life expectancy >3 months Key Exclusion Criteria: Greater than 3 lines of endocrine therapy for metastatic disease. Prior anti-cancer treatment or investigational drug therapy within the following windows: Tamoxifen or fulvestrant therapy < 42 days before 1st 18FES-PET scan Any other anti-cancer endocrine therapy < 14 days before 1st dose of study drug Any chemotherapy < 28 days before 1st dose of study drug 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth GE de Vries, MD
Organizational Affiliation
Universitair Medisch Centrum Groningen (UMCG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen (UMCG)
City
Groningen
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32912274
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.
Results Reference
derived

Learn more about this trial

Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

We'll reach out to this number within 24 hrs