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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02650817
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: RAD1901 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: Elacestrant (formerly RAD1901) Drug: RAD1901
RAD1901, a novel selective ER degrader (SERD)
Other Name: Elacestrant

Primary Outcome Measures :
  1. 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 Measures :
  1. Correlation of FES uptake after RAD1901 treatment to clinical response [ Time Frame: Every 8 weeks for to up 12 months of treatment ]
  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 ]
  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 ]
  4. Plasma concentrations of RAD1901 will be assessed at predefined intervals [ Time Frame: Every 28 days for up to 3 cycles ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02650817

Institut Jules Bordet
Bruxelles, Belgium, 1000
UZ Leuven Campus Gasthuisberg
Leuven, Belgium, 3000
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.

Responsible Party: Radius Pharmaceuticals, Inc. Identifier: NCT02650817     History of Changes
Other Study ID Numbers: RAD1901-106
2015-003555-22 ( EudraCT Number )
L54809.042.15 ( Other Identifier: ABR nr )
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs