Advanced ER+, HER2-Negative Breast CancerPhase 1NCT02338349
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
A Phase 1 study testing Elacestrant in people with Advanced ER+, HER2-Negative Breast Cancer, run by Stemline Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced ER+, HER2-Negative Breast Cancer
- What is being tested?
- Elacestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2020
- 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 must be post-menopausal women, as defined in the protocol
- 18 years or older
- Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
- Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
- Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
- Note: This list is not complete. Further inclusion criteria is provided in the protocol synopsis.
Who cannot join
- Prior anticancer or investigational drug treatment within the following windows:
- Tamoxifen therapy less than 14 days before first dose of study treatment
- Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
- Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
- Any chemotherapy less than 28 days before first dose of study
- Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
Show all 9Show fewer
- Patients with untreated or symptomatic central nervous system (CNS) metastases
- Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts
- Note: This list is not complete. Further exclusion criteria is provided in the protocol synopsis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Radius Pharmaceuticals, Inc.
Waltham, Massachusetts, 02451
About this study
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
Read the detailed description
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer.
The secondary objectives of this study are:
- To assess the safety and tolerability of elacestrant
- To evaluate the pharmacokinetics (PK) of elacestrant
- To evaluate the preliminary anti-tumor effect of elacestrant
- Being tested
- Elacestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
| Study group | Role | What they receive |
|---|---|---|
| Elacestrant | Experimental | Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant.
Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D.
Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD.
Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.
Measured: The first 28 days of treatment.
Secondary outcomes (3)
Safety and Tolerability of Elacestrant (RAD1901)
Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values.
Measured: Up to 30 days after the end of treatment.
Pharmacokinetics of Elacestrant (RAD1901)
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Measured: Every 28 days
Anti-Tumor Effect of Elacestrant (RAD1901)
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines.
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2019
- Study completionApr 2020
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 Advanced ER+, HER2-Negative 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director, Clinical Operations, Study director, Radius Pharmaceticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338349
- Sponsor's protocol ID
- RAD1901-005
- Status last verified
- May 2020
- First submitted
- 31 Dec 2014
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Bardia A, Kaklamani V, Wilks S, Weise A, Richards D, Harb W, Osborne C, Wesolowski R, Karuturi M, Conkling P, Bagley RG, Wang Y, Conlan MG, Kabos P. Phase I Study of Elacestrant (RAD1901), a Novel Selective Estrogen Receptor Degrader, in ER-Positive, HER2-Negative Advanced Breast Cancer. J Clin Oncol. 2021 Apr 20;39(12):1360-1370. doi: 10.1200/JCO.20.02272. Epub 2021 Jan 29.
PubMed 33513026
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 I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02338349
- Acronym / sponsor ID
- RAD1901-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 14 Jan 2015 (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 evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
Detailed description
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer.
The secondary objectives of this study are:
- To assess the safety and tolerability of elacestrant
- To evaluate the pharmacokinetics (PK) of elacestrant
- To evaluate the preliminary anti-tumor effect of elacestrant
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elacestrant | Experimental | Drug: ElacestrantPart A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant. Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D. Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD. Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history |
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 must be post-menopausal women, as defined in the protocol
- 18 years or older
- Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
- Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
- Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
Key exclusion criteria (9 listed)
- Prior anticancer or investigational drug treatment within the following windows:
- Patients with untreated or symptomatic central nervous system (CNS) metastases
- Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts
- Note: This list is not complete. Further exclusion criteria is provided in the protocol synopsis.
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 |
|---|---|---|
| Elacestrant | Drug | Elacestrant |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: The first 28 days of treatment.
To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.
3 secondary outcomes
Safety and Tolerability of Elacestrant (RAD1901)
Time frame: Up to 30 days after the end of treatment.
Pharmacokinetics of Elacestrant (RAD1901)
Time frame: Every 28 days
Anti-Tumor Effect of Elacestrant (RAD1901)
Time frame: Every 8 weeks
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 33513026Bardia A, Kaklamani V, Wilks S, Weise A, Richards D, Harb W, Osborne C, Wesolowski R, Karuturi M, Conkling P, Bagley RG, Wang Y, Conlan MG, Kabos P. Phase I Study of Elacestrant (RAD1901), a Novel Selective Estrogen Receptor Degrader, in ER-Positive, HER2-Negative Advanced Breast Cancer. J Clin Oncol. 2021 Apr 20;39(12):1360-1370. doi: 10.1200/JCO.20.02272. Epub 2021 Jan 29.
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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.
Sr. Director, Clinical Operations study director
Radius Pharmaceticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elacestrant in people with Advanced ER+, HER2-Negative Breast Cancer, run by Stemline Therapeutics, Inc. at 1 site in United States.
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 9 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 1 site in United States. 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?
Dose Limiting Toxicities (DLT) (time frame: The first 28 days of treatment.). 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 NCT02338349, 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.