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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-10-18

Brief Summary

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

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Detailed Description

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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

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elacestrant (formerly RAD1901)

To receive daily oral elacestrant

Group Type EXPERIMENTAL

RAD1901

Intervention Type DRUG

RAD1901, a novel selective ER degrader (SERD)

Interventions

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RAD1901

RAD1901, a novel selective ER degrader (SERD)

Intervention Type DRUG

Other Intervention Names

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Elacestrant

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No