AzTrials
AzTrials

Breast Neoplasm FemalePhase 3NCT03425838

Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer

A Phase 3 study testing CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor and Fulvestrant in people with Breast Neoplasm Female, run by Borstkanker Onderzoek Groep at 72 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm Female
What is being tested?
CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
72 sitesNetherlands
Study dates
9 Nov 2017to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
  • Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results.
  • Previously untreated with any systemic anti-cancer therapy for loco-regional recurrent or metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine therapy.
  • Women who are not post-menopausal must use LHRH agonist. Postmenopausal status is defined as:
  • prior bilateral surgical oophorectomy, or
  • spontaneous cessation of regular menses for at least 12 consecutive months without OAC
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  • in case of doubt serum estradiol <20 umol/l and follicle stimulating hormone (FSH) levels >15 IU/L at screening
  • Measurable or evaluable disease as defined per RECIST v.1.1 (see Appendix 3) or bone-only disease. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  • Adequate organ and marrow function defined as follows:
  • ANC ≥1,000/mm3 (1.0 x 10e9 /L);
  • Platelets ≥50,000/mm3 (50 x 10e9 /L);
  • Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution;
  • Total serum bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert's disease);
  • AST and ALT ≤3 x ULN (≤5.0 x ULN if liver metastases present);
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1, except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study before any study-specific activity is performed.

Who cannot join

  • Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable without the use of steroids for at least 4 weeks before randomization
  • Prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (i.e., anastrozole, letrozole or exemestane) with disease recurrence while on or within 12 months of treatment.
  • Prior treatment with any CDK4/6 inhibitor.
  • Patients treated within the last 7 days prior to randomization with:
  • Food or drugs that are known to be CYP3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit or grapefruit juice);
Show all 14Show fewer
  • Drugs that are known to be CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John's wort).
  • Major surgery, chemotherapy, radiotherapy, any investigational agents, or other anti-cancer therapy within 2 weeks before randomization. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received.
  • Diagnosis of any other malignancy prior to randomization, except those that are not believed to influence the patient's prognosis and do not require any further treatment. This includes, but is not limited to adequately treated basal cell or squamous cell skin cancer and carcinoma in situ of the cervix.
  • QTc >480 msec at baseline
  • Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.
  • Known hypersensitivity to letrozole or anastrozole, or any of its excipients, or to any palbociclib excipients.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Recent or active suicidal ideation or behavior.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

Netherlands72 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Noordwestziekenhuisgroep

    Alkmaar

  • ZGT

    Almelo

  • Flevoziekenhuis

    Almere Stad

  • Meander Medisch Centrum

    Amersfoort

  • Ziekenhuis Amstelland

    Amstelveen

  • Nki - Avl

    Amsterdam, 1066 CX

  • VUmc

    Amsterdam, 1081 HV

  • AMC

    Amsterdam

  • BovenIJ Ziekenhuis

    Amsterdam

  • OLVG

    Amsterdam

  • Gelre ziekenhuizen

    Apeldoorn

  • Rijnstate

    Arnhem

  • Wilhelmina ziekenhuis

    Assen

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Alexander Monro Ziekenhuis

    Bilthoven

  • Maasziekenhuis Pantein

    Boxmeer

  • Amphia

    Breda

  • IJsselland

    Capelle aan den IJssel

  • Reinier de Graaf

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Van Weel-Bethesda Ziekenhuis

    Dirksland

  • Slingeland Ziekenhuis

    Doetinchem

  • Albert Schweitzer ziekenhuis

    Dordrecht

  • Nij Smellinghe

    Drachten

  • Gelderse Vallei

    Ede

  • Catharina Ziekenhuis

    Eindhoven

  • Maxima Medisch Centrum

    Eindhoven

  • Treant Zorggroep

    Emmen

  • Medisch Spectrum Twente

    Enschede

  • St. Anna Ziekenhuis

    Geldrop

  • Admiraal de Ruyter

    Goes

  • Rivas Beatrixziekenhuis

    Gorinchem

  • Groene Hart Ziekenhuis

    Gouda

  • Martini Ziekenhuis

    Groningen

  • UMC Groningen

    Groningen

  • Ropcke Zweers

    Hardenberg

  • Sint Jansdal

    Harderwijk

  • Tjongerschans

    Heerenveen

  • Elkerliek ziekenhuis

    Helmond

  • Tergooi

    Hilversum

  • Spaarne Gasthuis

    Hoofddorp

  • Dijklander Ziekenhuis

    Hoorn

  • MC Leeuwarden

    Leeuwarden

  • Alrijne Ziekenhuis

    Leiden

  • LUMC

    Leiden

  • St. Antonius

    Nieuwegein

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen

  • Radboudumc

    Nijmegen

  • Laurentius

    Roermond

  • Bravis ziekenhuis

    Roosendaal

  • Erasmus MC

    Rotterdam, 3015 CE

  • Franciscus Gasthuis & Vlietland

    Rotterdam

  • Ikazia

    Rotterdam

  • Maasstad Ziekenhuis

    Rotterdam

  • Zuyderland

    Sittard

  • Antonius Ziekenhuis

    Sneek

  • Spijkenisse Medisch Centrum

    Spijkenisse

  • ZorgSaam

    Terneuzen

  • Haaglanden Medisch Centrum

    The Hague

  • HaGaziekenhuis

    The Hague

  • Ziekenhuis Rivierenland

    Tiel

  • Elisabeth Tweesteden

    Tilburg

  • Bernhoven

    Uden

  • Diakonessenhuis

    Utrecht

  • UMC Utrecht

    Utrecht

  • VieCuri

    Venlo

  • St. Jans Gasthuis

    Weert

  • Streekziekenhuis Koningin Beatrix

    Winterswijk

  • Zaans Medisch Centrum

    Zaandam

  • Langeland

    Zoetermeer

  • Isala

    Zwolle

Other trials in Netherlands

About this study

Official title: BOOG 2017-03: Endocrine Therapy Plus CDK 4/6 Inhibition in First- or Second-line for Hormone Receptor Positive Advanced Breast Cancer - the SONIA Study

Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 in second line.

Read the detailed description

Combining cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors with endocrine therapies in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer has shown to result in substantial improvements in progression-free survival. There is however no evidence that this combination strategy leads to an improved overall survival. Furthermore, no specific subgroups that will or will not benefit from the combination of drugs have been identified yet. This means the optimal strategy for deploying CDK 4/6 inhibitors in clinical practice is not yet known. Since CDK 4/6 inhibitors are costly and can have toxic effects, it is important to determine the optimal treatment strategy to avoid both over- and undertreatment.

The SONIA-trial is an investigator-initiated, multicenter, randomized phase III study. The primary objective of this study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK 4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free survival compared to treatment with a non-steroidal aromatase inhibitor in first line followed at progression by fulvestrant combined with CDK4/6 inhibition in second line (strategy B). The primary end point is progression-free survival after two lines (PFS2), secondary end points include overall survival, quality of life, safety and biomarker analyses.

Being tested
CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
Keywords
CDK 4/6 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDK 4/6 inhibitorDrug

    Also called palbociclib,Ibrance,ribociclib,Kisqali,abemaciclib,Verzenio

    Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer

  • Non-Steroidal Aromatase InhibitorDrug

    Also called NSAI, letrozole, Femara®, anastrozole, Arimidex®

    Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer

  • FulvestrantDrug

    Also called SERD, Faslodex®

    Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer

Study groups in NCT03425838
Study groupRoleWhat they receive
Strategy A CDK4/6 inhibitor in 1st lineActive comparatorNon-steroidal aromatase inhibitor (letrozole or anastrozole, at the discretion of the treating physician) plus CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib, depending on availability and physician's preference) in first line followed by fulvestrant in second line.
Receives: Drug: CDK 4/6 inhibitor; Drug: Non-Steroidal Aromatase Inhibitor; Drug: Fulvestrant
Strategy B CDK4/6 inhibitor in 2nd lineActive comparatorNon-steroidal aromatase inhibitor (letrozole or anastrozole, at the discretion of the treating physician) in first line followed by fulvestrant plus CDK4/6 inhibitor in second line (palbociclib, ribociclib or abemaciclib, depending on availability and physician's preference).
Receives: Drug: CDK 4/6 inhibitor; Drug: Non-Steroidal Aromatase Inhibitor; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS2

    Progression-free survival after two lines of treatment (PFS2)

    Measured: Until objective disease progression, symptomatic deterioration, or unacceptable toxicity on second line treatment, death, strategy violation, or withdrawal of consent, whichever occurs first, assessed up to 60 months

Secondary outcomes (15)

  1. OS

    Overall survival

    Measured: Date of randomization until date of death due to any cause, assessed up to 60 months

  2. FACT-B questionnaire

    Quality of Life questionnaire

    Measured: Questionnaires will be administered at baseline and thereafter every three months, up to 60 months

  3. EQ-5D questionnaire

    Quality of Life questionnaire

    Measured: Questionnaires will be administered at baseline and thereafter every three months, up to 60 months

  4. iMTA RUQ-B questionnaire

    Quality of Life questionnaire

    Measured: Questionnaires will be administered at baseline and thereafter every six months, up to 60 months

  5. Number of participants with grade 3 or 4 treatment-related neutropenia as assessed by CTCAE v4.0

    Safety assessment will consist of monitoring of all grade 3 and grade 4 neutropenia (absolute neutrophil count/L)

    Measured: Through study completion, assessed up to 60 months

  6. Number of participants with grade 3 or 4 treatment-related thrombocytopenia as assessed by CTCAE v4.0

    Safety assessment will consist of monitoring of all grade 3 and grade 4 thrombocytopenia (platelet count/L)

    Measured: Through study completion, assessed up to 60 months

  7. Number of participants with grade 3 or 4 treatment-related anemia as assessed by CTCAE v4.0

    Safety assessment will consist of monitoring of all grade 3 and grade 4 anemia (mmol/L)

    Measured: Through study completion, assessed up to 60 months

  8. Number of participants with grade 3 or 4 treatment-related elevated liver enzymes (ALAT/ASAT/AF/GGT/bilirubin) as assessed by CTCAE v4.0

    Safety assessment will consist of monitoring of all grade 3 and grade 4 elevated liver enzymes (elevation compared to upper limit of normal)

    Measured: Through study completion, assessed up to 60 months

  9. Number of participants with grade 3 or 4 treatment-related other toxicities as defined in CTCAE v4.0

    Safety assessment will consist of monitoring of all grade 3 and grade 4 other toxicities as defined in CTCAE v4.0

    Measured: Through study completion, assessed up to 60 months

  10. Cost-effectiveness by means of a decision model (a multistate Markov model or a Discrete Event Simulation model)

    The cost and outcomes of both arms will be assessed by means of a decision model (a multistate Markov model or a Discrete Event Simulation model). Cost-effectiveness will be determined by comparing costs and effects of both treatment strategies. Quality adjusted life years will be computed by multiplying life-years with the observed utility scores during those life years. The friction cost method will be used for estimating the societal costs of productivity losses. Unit costs for drugs will be derived from www.medicijnkosten.nl or the Z-index. The costs of a hospital day, outpatient visit, and day care treatment, will be based on the Dutch costing manual. Other costs will be collected from NZA tariffs. All costs will be expressed in Euros.

    Measured: At 60 months after entry into the study

  11. ORR

    Objective response rate

    Measured: Through study completion, assessed up to 60 months

  12. Plasma through levels

    Plasma through levels of CDK4/6 inhibitor measured in blood samples obtained at cycle 1, day 15 (of 28 days in one cycle) and at cycle 2, day 15 in participants treated with CDK4/6 inhibitors.

    Measured: Through study completement

  13. Pharmacogenomics

    DNA sequencing in a blood sample obtained at cycle 1, day 15 (of 28 days in one cycle) of treatment with CDK4/6 inhibitor.

    Measured: On day 15 of cycle 1 (a cycle is 28 days)

  14. Liquid biopsies

    Circulating tumor DNA isolated from blood samples collected at 7 timepoints during the study. Mutation level during the study and at disease progression will be compared to base-line mutation level.

    Measured: At baseline of first line, at cycle 1 day 15 (a cycle is 28 days), at cycle 4 day 1, at baseline of second line, at cycle 1 day 15 (a cycle is 28 days), at cycle 4 day 1 and at disease progression

  15. Tissue microarray

    Tissue microarray on archived FFPE tissue blocks of the tumor

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start9 Nov 2017
  3. Primary completion6 Mar 2023
  4. Study completionDec 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425838
Sponsor's protocol ID
BOOG 2017-03
Other IDs
2017-002334-23, 2017
Status last verified
Sep 2025
First submitted
15 Jun 2017
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers.

Publications

  • Wortelboer N, van Ommen-Nijhof A, Konings IR, van der Noort V, van den Pol E, Guerrero Paez C, Bakker SD, Hovenga S, Imholz ALT, Kamm YJL, van Leeuwen L, Luykx-de Bakker SA, Mandigers CMPW, van Riel JMGH, Tol J, van de Wouw AJ, Wilting SM, van Leeuwen-Stok AE, Jager A, Sonke GS. Overall Survival With First-Line vs Second-Line CDK4/6 Inhibitor Use in Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2026 Apr 1;12(4):375-383. doi: 10.1001/jamaoncol.2025.6585.

    PubMed 41712229

  • Wortelboer N, Kent S, Blommestein HM, van Ommen-Nijhof A, van der Noort V, van den Pol E, Paez CG, Beeker A, Beelen K, Hamming LC, Heijns JB, Honkoop AH, de Jong PC, van Rossum-Schornagel QC, van Schaik-van de Mheen C, Tol J, Tromp-van Driel CS, Vrijaldenhoven S, van Leeuwen-Stok AE, Sonke GS, Jager A, Konings IR. Health-related quality of life with first- vs second-line CDK4/6 inhibitor use in advanced breast cancer: results from the SONIA trial. J Natl Cancer Inst. 2026 Mar 1;118(3):502-510. doi: 10.1093/jnci/djaf334.

    PubMed 41270788

  • Wortelboer N, Kent S, Konings IR, van Ommen-Nijhof A, van der Noort V, van den Pol E, Guerrero Paez C, van Bekkum ML, van den Berkmortel FWPJ, Droogendijk HJ, Houtsma D, Oosterkamp HM, van der Padt-Pruijsten A, Siemerink EJM, Tol J, van Zweeden AA, van Leeuwen-Stok AE, Sonke GS, Jager A, Blommestein HM. Health economic outcomes and costs of CDK4/6 inhibitor use in first- versus second-line for advanced breast cancer: A cost-effectiveness analysis of the phase 3 SONIA trial. Eur J Cancer. 2025 Dec 9;231:116051. doi: 10.1016/j.ejca.2025.116051. Epub 2025 Oct 25.

    PubMed 41207182

  • Jongbloed EM, Wortelboer N, de Weerd V, Beaufort CM, Ruigrok-Ritstier K, Van MN, Kraan J, van Zweeden AA, van der Padt-Pruijsten A, Hamming LC, Konings IR, Sonke GS, Oomen-de Hoop E, Martens JWM, Jager A, Wilting SM. Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer: circulating tumor DNA analysis of a randomized phase 3 trial. Nat Med. 2025 Nov;31(11):3662-3667. doi: 10.1038/s41591-025-03935-w. Epub 2025 Sep 4.

    PubMed 40908356

  • van Ommen-Nijhof A, Konings IR, van Zeijl CJJ, Uyl-de Groot CA, van der Noort V, Jager A, Sonke GS; SONIA study steering committee. Selecting the optimal position of CDK4/6 inhibitors in hormone receptor-positive advanced breast cancer - the SONIA study: study protocol for a randomized controlled trial. BMC Cancer. 2018 Nov 20;18(1):1146. doi: 10.1186/s12885-018-4978-1.

    PubMed 30458732

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor and Fulvestrant in people with Breast Neoplasm Female, run by Borstkanker Onderzoek Groep at 72 sites in Netherlands.

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 18 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

PFS2 (time frame: Until objective disease progression, symptomatic deterioration, or unacceptable toxicity on second line treatment, death, strategy violation, or withdrawal of consent, whichever occurs first, assessed up to 60 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 NCT03425838, which also lists 5 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 20 May 2026.

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