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Completed

NCT Number: NCT02650817

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

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Institut Jules Bordet, Brussels, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAD1901

Drug

RAD1901, a novel selective ER degrader (SERD)

Other names: Elacestrant

Primary outcomes

  1. Effect of ER Binding after RAD1901 treatment

    Time frame: 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 outcomes

  1. Correlation of FES uptake after RAD1901 treatment to clinical response

    Time frame: 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

  2. Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines

    Time frame: Every 8 weeks for to up 12 months of treatment

    To determine if there is a tumor response to RAD1901 treatment

  3. Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values

    Time frame: Up to 30 days after the end of treatment

    Characterization of the safety of RAD1901 in this patient population

  4. Plasma concentrations of RAD1901 will be assessed at predefined intervals

    Time frame: Every 28 days for up to 3 cycles

    Pharmacokinetic data will be collected.

Sponsors and collaborators

Lead sponsor

Stemline Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 8, 2016
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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