NCT02650817

Brief Summary

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2019

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.4 years

First QC Date

January 6, 2016

Last Update Submit

August 16, 2022

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

    14 Days after the first dose

Secondary Outcomes (4)

  • Correlation of FES uptake after RAD1901 treatment to clinical response

    Every 8 weeks for to up 12 months of treatment

  • 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

  • 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

  • Plasma concentrations of RAD1901 will be assessed at predefined intervals

    Every 28 days for up to 3 cycles

Study Arms (1)

Elacestrant (formerly RAD1901)

EXPERIMENTAL

To receive daily oral elacestrant

Drug: RAD1901

Interventions

RAD1901DRUG

RAD1901, a novel selective ER degrader (SERD)

Also known as: Elacestrant
Elacestrant (formerly RAD1901)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Leuven Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Vrije Universiteit Medisch Centrum (VUMC)

Amsterdam, Netherlands

Location

Universitair Medisch Centrum Groningen (UMCG)

Groningen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 32912274DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RAD1901elacestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elisabeth GE de Vries, MD

    Universitair Medisch Centrum Groningen (UMCG)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

April 1, 2016

Primary Completion

August 30, 2018

Study Completion

October 18, 2019

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)BE(2)