Metastatic Breast CancerPhase 1NCT02650817
Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer
A Phase 1 study testing RAD1901 in people with Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- RAD1901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Apr 2016to 18 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands3 sites
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam
Universitair Medisch Centrum Groningen (UMCG)
Groningen
Erasmus Medical Center
Rotterdam
Belgium2 sites
Institut Jules Bordet
Brussels, 1000
UZ Leuven Campus Gasthuisberg
Leuven, 3000
About this study
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
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)
Read the detailed 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
- Conditions
- Metastatic Breast Cancer
- Being tested
- RAD1901
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD1901Drug
Also called Elacestrant
RAD1901, a novel selective ER degrader (SERD)
| Study group | Role | What they receive |
|---|---|---|
| Elacestrant (formerly RAD1901) | Experimental | To receive daily oral elacestrant Receives: Drug: RAD1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 Days after the first dose
Secondary outcomes (4)
Correlation of FES uptake after RAD1901 treatment to clinical response
To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response
Measured: 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
To determine if there is a tumor response to RAD1901 treatment
Measured: 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
Characterization of the safety of RAD1901 in this patient population
Measured: Up to 30 days after the end of treatment
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Pharmacokinetic data will be collected.
Measured: Every 28 days for up to 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start1 Apr 2016
- Primary completion30 Aug 2018
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth GE de Vries, MD, Principal investigator, Universitair Medisch Centrum Groningen (UMCG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650817
- Sponsor's protocol ID
- RAD1901-106
- Other IDs
- 2015-003555-22, L54809.042.15, 2015
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32912274
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02650817
- Acronym / sponsor ID
- RAD1901-106
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elacestrant (formerly RAD1901) | Experimental | Drug: RAD1901To receive daily oral elacestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Greater than 3 lines of endocrine therapy for metastatic disease.
- Prior anti-cancer treatment or investigational drug therapy within the following windows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD1901Also: ElacestrantRAD1901, a novel selective ER degrader (SERD) | Drug | Elacestrant (formerly RAD1901) |
Primary outcome
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)
4 secondary outcomes
Correlation of FES uptake after RAD1901 treatment to clinical response
Time frame: 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
Time frame: 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
Time frame: Up to 30 days after the end of treatment
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Time frame: Every 28 days for up to 3 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 32912274Jager 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth GE de Vries, MD principal investigator
Universitair Medisch Centrum Groningen (UMCG)
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD1901 in people with Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ER Binding after RAD1901 treatment (time frame: 14 Days after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.