Metastatic Breast CancerPhase 2ELAINEIINCT04432454
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
A Phase 2 study testing Lasofoxifene and abemaciclib (VERZENIO (R)). in people with Metastatic Breast Cancer, run by Sermonix Pharmaceuticals Inc. at 16 sites in United States.
Trial summary
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of… 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?
- Lasofoxifene and abemaciclib (VERZENIO (R)).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Sep 2020to 28 Jan 2025
- Phase
- Phase 2
- 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
- Pre- or postmenopausal.
- Postmenopausal women are defined as:
- ≥ 60 years of age with no vaginal bleeding over the prior year, or
- < 60 years with "premature menopause" or "premature ovarian failure" manifest itself with secondary amenorrhea for at least 1 year and follicle stimulating hormone (FSH) and estradiol levels in the postmenopausal range according to institutional standards, or
- surgical menopause with bilateral oophorectomy. Note: Premenopausal women who meet all of the other entry criteria must be maintained on ovarian suppression (such as Lupron) during the study and subjects counseled to use appropriate contraception to prevent pregnancy.
- If possible, a biopsy of metastatic breast cancer tissue should be obtained to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is not possible, the ER and HER2 status from the tissue obtained at the time of the original diagnosis must confirm that the subject is ER+ and HER2-.
Show all 25Show fewer
- Locally advanced and/or metastatic breast cancer with radiological or clinical evidence of progression on the first or 2nd lines of hormonal therapy for metastatic disease. Progression may have occurred on no more than 2 of the following endocrine treatments for metastatic breast cancer: an aromatase inhibitor (AI) and/or fulvestrant either as monotherapy or in combination with any commercially approved CDKi; and/or the combination of fulvestrant and everolimus; and/or the combination of fulvestrant and alpelisib; and/or tamoxifen; and/or the combination of exemestane/everolimus. (Note: before starting study treatment, subjects should have stopped any CDKi for at least 21 days)
- Subjects must have had no evidence of progression for at least 6 months during their first hormonal treatment for advanced breast cancer.
- At least one or more of the following ESR1 point mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. Note: the Sponsor's blood ctDNA assay must be used but tissue sequencing (if done) may be done by a validated commercial laboratory.
- Note: A positive ESR1 mutation in tissue or ctDNA using a validated commercial assay if done prior or at the time of disease progression is acceptable to meet this entry criteria. However, blood for ctDNA must still be obtained for genomic analyses using the sponsor's ctDNA assay.
- Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
- Subjects may have received one cytotoxic chemotherapy regimen for metastatic disease as well as those who received one cytotoxic chemotherapy regimen in the neo-adjuvant or adjuvant setting prior to entry into the trial can be enrolled but must be free of all chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy before study entry. A washout period of at least 21 days is required between last chemotherapy dose and entry into the study.
- Stable breast cancer metastasis to the brain is allowed as long as the subject has received radiotherapy and not demonstrated any evidence of brain metastasis progression for at least 3 months after the completion of radiotherapy.
- ECOG performance score of 0 or 1.
- Adequate organ function as shown by:
- absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- platelet count ≥ 100,000 cells/mm3
- hemoglobin ≥ 8.0 g/dl
- ALT and AST levels ≤ 3 upper limit of normal (ULN) or ≤ 5 in the presence of liver metastasis
- total serum bilirubin ≤ 1.5 X ULN (≤ 3 X ULN for subjects known to have Gilbert Syndrome)
- alkaline phosphatase level ≤ 3 ULN
- creatinine clearance of 40 ml/min or greater as calculated by the Cockcroft-Gault formula
- International normalized ratio (INR) and activated partial thromboplastin (aPTT) < 2.0 X ULN
- Able to swallow tablets.
- Able to understand and voluntarily sign a written informed consent before any screening procedures.
Who cannot join
- Lymphangitic carcinomatosis involving the lung.
- Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
- Radiotherapy within 30 days prior to entry into the study except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to entry into the study. Subjects must have recovered from radiotherapy toxicities prior to entry into the study.
- Subjects with known inactivating RB1 mutations or deletions (Screening for RB1 mutation is not required for entry).
- History of long QTC syndrome or a QTC of > 480 msec.
- History of a pulmonary embolus (PE) or deep vein thrombosis (DVT) within the last 6 months or any known thrombophilia. Subjects stable on anti-coagulants for maintenance are eligible as long as the DVT and/or PE occurred > 6 months prior to enrollment and there is no evidence for active thrombosis. The use of low-dose ASA is permitted.
Show all 17Show fewer
- Subjects on concomitant strong CYP3A4 inhibitors such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir.
- Subjects on strong and moderate CYP3A4 inducers such as amprenavir, barbiturates, carbamazepine, clotrimazole, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, chronic prednisone treatment, primidone, rifabutin, rifampin, rifapentine, ritonavir, topiramate.
- Any significant co-morbidity that would impact the study or the subject's safety. Since CDKi have reported the occurrence of interstitial lung disease (ILD), subjects with a history of ILD and those with severe dyspnea at rest or requiring oxygen therapy should not enter the study
- Subject has an active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics at the time of initiating study treatment).
- History of a positive human immunodeficiency virus (HIV) or hepatitis B virus (HBV) test. Screening is not required for enrollment.
- Subjects with hepatitis C virus (HCV) at Screening who still have a viral load. Subjects previously treated and achieved a HCV cure (no viral load) can be entered into the study
- History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery, or early-stage cervical cancer.
- Positive serum pregnancy test (only if premenopausal).
- History of non-compliance to medical regimens.
- Unwilling or unable to comply with the protocol.
- Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
New Jersey Cancer Care, PA
Belleville, New Jersey, 07109
University of Alabama at Birmingham (UAB) - Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mary Crowley Cancer Research
Dallas, Texas, 75230
Compassionate Cancer Care Med Group - Clinic Aid USA - Fountain Valley
Fountain Valley, California, 92708
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Oncology Consultants, P.A.
Houston, Texas, 77030
Mayo Jacksonville
Jacksonville, Florida, 32224
Illinois Cancer Care
Peoria, Illinois, 61704
Mayo Clinic Rochester
Rochester, Minnesota, 55905
St. Joseph Health
Santa Rosa, California, 95403
Beacon Health System Memorial Regional Cancer Center
South Bend, Indiana, 46601
Northwest Medical Specialists, PLLC (NWMS)
Tacoma, Washington, 98405
Yuma Regional Medical Center
Yuma, Arizona, 85364
About this study
Official title: An Open-label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lasofoxifene and abemaciclib (VERZENIO (R)).
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lasofoxifene and abemaciclib (VERZENIO (R)).Drug
Lasofoxifene 5 mg given once a day orally and abemaciclib 150 mg given twice a day orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Women who have locally advanced or metastatic ER+/HER2- breast cancer and disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation Receives: Drug: Lasofoxifene and abemaciclib (VERZENIO (R)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the combination of lasofoxifene and abemaciclib as measured by number of adverse events (AEs), severity of AEs and mortality due to AEs at every scheduled visit.
AEs will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. Safety and tolerability will be assessed from enrollment up to 24 months.
Secondary outcomes (6)
Progression free survival (PFS)
PFS is defined as the time from the date of entry into the study to the earliest date of first documented progression or death due to any cause.
Measured: Up to 24 months
Clinical benefit rate (CBR)
Measured: 24 weeks or longer
Objective response rate (ORR)
Measured: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. ORR will be assessed up to 24 months.
Duration of response (DoR)
DoR is from the date of first documented response (CR or PR) to the date of first documented progression of disease or death due to any cause.
Measured: DoR will be assessed up to 24 months.
Time to response
From the date of entry into the study to the date of first documented response (CR or PR).
Measured: Time to response will be assessed up to 24 months.
Steady-state pharmacokinetics (PK) sampling for lasofoxifene and abemaciclib concentrations as well as abemaciclib's 3 major metabolites
Measured: Baseline and pre-dose at every visit starting at Visit 0 (Day 1) through Visit 4 (Week 8) and at the Final/ET visit if this occurred prior to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start29 Sep 2020
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sermonix Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432454
- Sponsor's protocol ID
- SMX 20-001
- Acronym
- ELAINEII
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Damodaran S, O'Sullivan CC, Elkhanany A, Anderson IC, Barve M, Blau S, Cherian MA, Peguero JA, Goetz MP, Plourde PV, Portman DJ, Moore HCF. Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2- breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023 Dec;34(12):1131-1140. doi: 10.1016/j.annonc.2023.09.3103.
PubMed 38072513Blau S, Peguero JA, Moore HCF, Anderson IC, Barve MA, Cherian MA, Elkhanany A, O'Sullivan CC, Moreno-Aspitia A, Plourde P, Gleich LL, Riesen K, Ezzati R, Degele M, Shulman M, Stempf SD, Sachse L, Iyer AA, Damodaran S, Cooney MM. Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model. JCO Clin Cancer Inform. 2023 Jun;7:e2200164. doi: 10.1200/CCI.22.00164.
PubMed 37352479
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )
- ClinicalTrials.gov ID
- NCT04432454
- Acronym / sponsor ID
- ELAINEII / SMX 20-001
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sermonix Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Lasofoxifene and abemaciclib (VERZENIO (R)).Women who have locally advanced or metastatic ER+/HER2- breast cancer and disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Pre- or postmenopausal.
- If possible, a biopsy of metastatic breast cancer tissue should be obtained to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is not possible, the ER and HER2 status from the tissue obtained at the time of the original diagnosis must confirm that the subject is ER+ and HER2-.
- Locally advanced and/or metastatic breast cancer with radiological or clinical evidence of progression on the first or 2nd lines of hormonal therapy for metastatic disease. Progression may have occurred on no more than 2 of the following endocrine treatments for metastatic breast cancer: an aromatase inhibitor (AI) and/or fulvestrant either as monotherapy or in combination with any commercially approved CDKi; and/or the combination of fulvestrant and everolimus; and/or the combination of fulvestrant and alpelisib; and/or tamoxifen; and/or the combination of exemestane/everolimus. (Note: before starting study treatment, subjects should have stopped any CDKi for at least 21 days)
- Subjects must have had no evidence of progression for at least 6 months during their first hormonal treatment for advanced breast cancer.
- At least one or more of the following ESR1 point mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. Note: the Sponsor's blood ctDNA assay must be used but tissue sequencing (if done) may be done by a validated commercial laboratory.
Key exclusion criteria (17 listed)
- Lymphangitic carcinomatosis involving the lung.
- Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
- Radiotherapy within 30 days prior to entry into the study except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to entry into the study. Subjects must have recovered from radiotherapy toxicities prior to entry into the study.
- Subjects with known inactivating RB1 mutations or deletions (Screening for RB1 mutation is not required for entry).
- History of long QTC syndrome or a QTC of > 480 msec.
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 |
|---|---|---|
| Lasofoxifene and abemaciclib (VERZENIO (R)).Lasofoxifene 5 mg given once a day orally and abemaciclib 150 mg given twice a day orally. | Drug | Treatment |
Primary outcome
Safety and tolerability of the combination of lasofoxifene and abemaciclib as measured by number of adverse events (AEs), severity of AEs and mortality due to AEs at every scheduled visit.
Time frame: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. Safety and tolerability will be assessed from enrollment up to 24 months.
AEs will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
6 secondary outcomes
Progression free survival (PFS)
Time frame: Up to 24 months
Clinical benefit rate (CBR)
Time frame: 24 weeks or longer
Objective response rate (ORR)
Time frame: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. ORR will be assessed up to 24 months.
Duration of response (DoR)
Time frame: DoR will be assessed up to 24 months.
Time to response
Time frame: Time to response will be assessed up to 24 months.
Steady-state pharmacokinetics (PK) sampling for lasofoxifene and abemaciclib concentrations as well as abemaciclib's 3 major metabolites
Time frame: Baseline and pre-dose at every visit starting at Visit 0 (Day 1) through Visit 4 (Week 8) and at the Final/ET visit if this occurred prior to Week 8
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 13 Feb 2025.
- Derived from this study: PubMed 38072513Damodaran S, O'Sullivan CC, Elkhanany A, Anderson IC, Barve M, Blau S, Cherian MA, Peguero JA, Goetz MP, Plourde PV, Portman DJ, Moore HCF. Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2- breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023 Dec;34(12):1131-1140. doi: 10.1016/j.annonc.2023.09.3103.
- Derived from this study: PubMed 37352479Blau S, Peguero JA, Moore HCF, Anderson IC, Barve MA, Cherian MA, Elkhanany A, O'Sullivan CC, Moreno-Aspitia A, Plourde P, Gleich LL, Riesen K, Ezzati R, Degele M, Shulman M, Stempf SD, Sachse L, Iyer AA, Damodaran S, Cooney MM. Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model. JCO Clin Cancer Inform. 2023 Jun;7:e2200164. doi: 10.1200/CCI.22.00164.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lasofoxifene and abemaciclib (VERZENIO (R)). in people with Metastatic Breast Cancer, run by Sermonix Pharmaceuticals Inc. at 16 sites 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 25 inclusion and 17 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of the combination of lasofoxifene and abemaciclib as measured by number of adverse events (AEs), severity of AEs and mortality due to AEs at every scheduled visit. (time frame: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. Safety and tolerability will be assessed from enrollment up to 24 months.). 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 NCT04432454, which also lists 2 linked publications.
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 13 Feb 2025.