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

Stemline Therapeutics

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer

Treatments: Drug: RAD1901

Study type: Interventional

Funder types: Other

Identifiers

NCT02650817

L54809.042.15 (Other Identifier)

RAD1901-106

2015-003555-22 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Elacestrant (formerly RAD1901)

Experimental group

Description:

To receive daily oral elacestrant

Treatment:

Drug: RAD1901