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Metastatic Breast CancerPhase 3PADA-1NCT03079011

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

A Phase 3 study testing Palbociclib 125mg, Aromatase Inhibitors and Fulvestrant Injectable Product in people with Metastatic Breast Cancer, run by UNICANCER at 82 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA… 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?
Palbociclib 125mg, Aromatase Inhibitors and Fulvestrant Injectable Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,017 participants
Where
82 sitesFrance
Study dates
22 Mar 2017to 22 Sep 2025
Phase
Phase 3
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

  • Women with proven loco-regionally recurrent or metastatic adenocarcinoma of the breast not amenable to curative therapy with disease considered potentially sensitive to aromatase inhibitors Note: patients relapsing while on adjuvant tamoxifen or other non-aromatase inhibitor adjuvant endocrine therapy and patients relapsing more than one year after the end of aromatase inhibitor adjuvant therapy are eligible for the present study;
  • Age ≥18 years;
  • Life expectancy >3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
  • Estrogen Receptor (ER)-positive and HER2-negative breast cancer. Where available, assessment of Estrogen Receptor status should be based on the most recent tumor sample; to be considered as ER-positive, the most recent breast cancer tissue examined must display at least 10% of cancer cells with positive ER staining;
  • Tumor block (primary tumor or metastasis) available;
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  • No prior systemic anti-cancer therapy for metastatic or advanced disease (chemotherapy, targeted therapy or hormone therapy); prior initiation of LHRH agonist or bone-directed agents is however allowed);
  • Menopausal patients or patients with suppressed ovarian function
  • Women with bilateral oophorectomy
  • Postmenopausal women, as defined by any of the following criteria:
  • Age 60 or over;
  • Age 50 to 59 years and meets one of the following criteria:
  • Amenorrhea for ≥24 months and follicle-stimulating hormone within the postmenopausal range;
  • patients with hysterectomy or chemotherapy-induced amenorrhea must display follicle-stimulating hormone within the postmenopausal range;
  • Other women, provided they are being treated with monthly LHRH analogues (first injection performed ≥7 days before the treatment initiation) and are willing to continue to receive LHRH agonist therapy for the duration of the trial;
  • Patients may have measurable (according to Response Evaluation Criterion in Solid Tumors (RECIST v1.1) or not measurable disease
  • Patients with only blastic bone lesions are not eligible;
  • Patients with only pleural, cardiac or peritoneal effusion or meningeal carcinomatosis are not eligible;
  • Adequate organ and marrow function as defined below:
  • Hemoglobin ≥90 g/L
  • Absolute neutrophil count ≥1.5 g/L
  • Platelet count ≥100 g/L
  • Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome.
  • ALT and AST ≤3 × ULN;
  • Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN if bone or liver metastases present)
  • Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥ 60 mL/min as determined by Cockcroft-Gault (using actual body weight) formula for females [creatinine clearance =Weight (kg) × (140 - Age) × 0.85 (mL/min)/ (72 × serum creatinine (mg/dL))
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations;
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.03 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion);
  • Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations;
  • Patient affiliated to a social security system.

Who cannot join

  • Locally advanced breast cancer or loco-regional relapse amenable for any treatment with curative intent;
  • Her2-positive or equivocal tumor status either on the primary or on the recurrent tumor, defined as IHC3+, Fish/Cish amplified or Fish/Cish equivocal according to the ASCO2015 criteria;
  • Prior endocrine therapy in the metastatic setting is not allowed;
  • Prior treatment with any CDK 4/6 inhibitor in the adjuvant or metastatic setting (neoadjuvant/preoperative treatment is allowed); however, prior therapy with another targeted treatment in the adjuvant setting is allowed;
  • Visceral crisis: Advanced, symptomatic, visceral spread that is at risk of life-threatening complication in the short term and that requires chemotherapy;
  • Any major surgery (defined as requiring general anaesthesia) or significant traumatic injury within 4 weeks of treatment initiation or patients that may require major surgery during the course of the study; however, surgical diagnostic procedure is allowed (even if performed under general anaesthesia);
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  • Known, active bleeding diathesis;
  • Any serious known concomitant systemic disorder (e.g. known active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti-coagulation treatment (the use of low molecular weight heparin is allowed);
  • Patients unable to swallow tablets;
  • History of mal-absorption syndrome or other condition that would interfere with enteral absorption;
  • Chronic daily treatment with corticosteroids with a dose of ≥10 mg/day methylprednisolone equivalent (excluding inhaled steroids);
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral oedema, 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 and off anticonvulsants and steroids for at least 4 weeks before treatment start;
  • Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant, palbociclib or any of their excipients;
  • Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia);
  • Patients treated within the last 7 days prior to treatment start in the trial with drug that are known to be CYP3A4 inhibitors, drugs that are known to be CIP3A4 inducers, who underwent a grapefruit cure;
  • Patients already included in another therapeutic trial evaluating an investigational medicinal product or having received an investigational medicinal product within 3 months;
  • History of previous:
  • Any other stage II, III, IV cancer within 5 years preceding patient enrollment in the trial - however, multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumor masses were ER+;
  • Any history of hematological malignancy;
  • Persons deprived of their freedom or under guardianship or incapable of giving consent;
  • Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LHRH agonist cannot be considered as an efficient contraceptive measure) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months.

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

France82 sites

  • Centre Hospitalier Universitaire

    Amiens

  • Clinique de l'Europe

    Amiens

  • Institut de Cancérologie de l'Ouest - Site Paul Papin

    Angers

  • Centre Hospitalier d'Auxerre

    Auxerre

  • Institut Sainte Catherine

    Avignon

  • Centre Hospitalier de Beauvais

    Beauvais

  • Centre Hospitalier de Blois

    Blois

  • Clinique Tivoli Ducos

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

  • Centre Hospitalier de boulogne sur Mer

    Boulogne-sur-Mer

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse

  • CHRU Morvan

    Brest

  • Clinique PASTEUR-CFRO

    Brest

  • Centre Francois Baclesse

    Caen

  • Centre Hospitalier René Dubos

    Cergy-Pontoise

  • Medipole de Savoie

    Challes-les-Eaux

  • Centre Hôpital Sainte Marie

    Chalon-sur-Saône

  • CH William Morey

    Chalon-sur-Saône

  • Centre Hospitalier Métropole de Savoie

    Chambéry

  • Centre Hospitalier de Cholet

    Cholet

  • Centre Jean Perrin

    Clermont-Ferrand

  • Pôle Santé République

    Clermont-Ferrand

  • Centre Georges François Leclerc

    Dijon

  • CHI Fréjus St-Raphaël

    Fréjus

  • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

    Grenoble

  • Centre Hospitalier Départemental de Vendée

    La Roche-sur-Yon

  • Clinique du Cap d'Or

    La Seyne-sur-Mer

  • Centre Hospitalier de Versailles

    Le Chesnay

  • Centre Hospitalier le Mans

    Le Mans

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret

  • CHU Dupuytren

    Limoges

  • Clinique François Chénieux

    Limoges

  • Centre Hospitalier Bretagne Sud

    Lorient

  • Centre Leon Berard

    Lyon

  • Clinique de la Sauvegarde

    Lyon

  • Hôpital privé Jean Mermoz

    Lyon

  • Centre d'Oncologie radiothérapie de Macon

    Mâcon

  • Hôpital Européen Marseille

    Marseille

  • Hôpital Saint Joseph

    Marseille

  • Institut Paoli Calmettes

    Marseille

  • Clinique Claude Bernard

    Metz

  • Centre Hospitalier ANNECY GENEVOIS

    Metz-Tessy

  • CH Mont de Marsan

    Mont-de-Marsan

  • Centre Hospitalier Montceau les mines

    Montceau-les-Mines

  • ICM - Val d'Aurelle

    Montpellier

  • Centre d'Oncologie de Gentilly

    Nancy

  • Hopital Privé du Confluent

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Centre ONCOGARD - Institut de Cancérologie du Gard

    Nîmes

  • Institut Curie

    Paris, 75005

  • Hopital Diaconesses-Croix Saint Simon

    Paris

  • Hopital Européen Georges Pompidou

    Paris

  • Saint Louis Hospital

    Paris

  • Centre Hospitalier de Pau

    Pau

  • Polyclinique Francheville

    Périgueux

  • Centre Catalan d'Oncologie

    Perpignan

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

    Plérin

  • Centre Hospitalier de Cornouaille

    Quimper

  • Clinique de la Croix du Sud

    Quint-Fonsegrives

  • Centre Eugène Marquis

    Rennes

  • Centre de radiothérapie et d'oncologie médicale LE-CROME

    Ris-Orangis

  • Centre Henri Becquerel

    Rouen

  • Centre Hospitalier Saint-Brieuc

    Saint-Brieuc

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud

  • CHP Saint Grégoire

    Saint-Grégoire

  • Institut de Cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

  • Institut de cancérologie lucien Neuwith

    Saint-Priest-en-Jarez

  • Centre Hospitalier de Broussais

    St-Malo

  • Centre Paul Stauss

    Strasbourg

  • Clinique de l'Orangerie

    Strasbourg

  • Clinique Sainte Anne

    Strasbourg

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Hôpitaux du Léman

    Thonon-les-Bains

  • Clinique Pasteur

    Toulouse

  • Institut Claudius Regaud

    Toulouse

  • Centre Hospitalier de Tours - Hopital Bretonneau

    Tours

  • Centre Hospitalier Bretagne Atlantique

    Vannes

  • UNEOS Site Hôpital Robert Schuman

    Vantoux

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients

This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.

Being tested
Palbociclib 125mg, Aromatase Inhibitors, Fulvestrant Injectable Product
Keywords
ESR1 mutation detection, ctDNA
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Palbociclib 125mgDrug

    Palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle

  • Aromatase InhibitorsDrug

    Also called Letrozole, Anastrozole or exemestane

    Letrozole: 2.5 mg once daily on a continuous scheme (tablets, per os) Anastrozole:1 mg once daily on a continuous scheme (tablets , per os) Exemestane: 25 mg once daily on a continuous scheme (tablets, per os)

  • Fulvestrant Injectable ProductDrug

    500 mg by intramuscular injection on days 1 and 15 of cycle one and then on day one of each subsequent cycle (28 days)

Study groups in NCT03079011
Study groupRoleWhat they receive
A- palbociclib + AIExperimentalAfter randomization, the patient will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with an aromatase inhibitor (letrozole, anastrozole or exemestane, according to physician's choice and according their respective summary product characteristics) administered once daily in a continuous scheme.
Receives: Drug: Palbociclib 125mg; Drug: Aromatase Inhibitors
B- Palbociclib + fulvestrantExperimentalAfter randomization, the patient will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with fulvestrant, a selective estrogen receptor down-regulator, 500 mg administered intramuscularly on Days 1, 15, and 29 and once monthly thereafter.
Receives: Drug: Palbociclib 125mg; Drug: Fulvestrant Injectable Product
Selection - Palbociclib + AIExperimentalAll patients included into the study will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with an aromatase inhibitor (letrozole, anastrozole or exemestane, according to physician's choice and according their respective summary product characteristics) administered once daily in a continuous scheme
Receives: Drug: Palbociclib 125mg; Drug: Aromatase Inhibitors

What is being measured

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

  1. Incidence of treatment-emergent Adverse Events

    Global safety of the combination of palbociclib + endocrine therapy in the whole population, with focus on hematological toxicities.

    Safety will be assessed by the collection of grade ≥3 adverse events, using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 - in all included patients.

    Measured: Throughout study completion, up to 4 years

  2. Progression-free survival (Step 2)

    To assess whether a change of the hormone therapy associated with palbociclib will benefit patients for whom rising ESR1 mutations are detected during treatment with palbociclib and aromatase inhibitor.

    Progression-Free Survival (PFS) will be measured from the time of randomization to the time of tumor progression (as assessed by the investigator per RECIST v1.1) or death (whichever comes first) - in randomized patients.

    Measured: From randomization to disease progression or death, up to 4 years

Secondary outcomes (8)

  1. Progression-free survival (step 3)

    To assess PFS in patients undergoing a cross-over following RECIST tumor progression in Arm A, from the start of crossover.

    Progression-Free Survival will be measured from the time of cross-over to the time of tumor progression (as assessed by the investigator per RECIST 1.1) or death (whichever comes first) - in all patients with crossover

    Measured: From cross-over, up to 4 years

  2. Progression-free survival (step 1&2)

    To report efficacy (PFS based on RECIST) of palbociclib combined with hormone therapy (aromatase inhibitor or fulvestrant), from the date of initial inclusion into the trial.

    Progression-Free Survival will be measured from the time of inclusion to the time of tumor progression (as assessed by the investigator per RECIST 1.1) or death (whichever comes first) - in all included patients including those who switched to fulvestrant.

    Measured: From inclusion, up to 4 years

  3. Time to strategy failure from randomization (Step 2 and 3)

    To assess whether the early switch (switch following ESR1 mutations increase) to fulvestrant contributes to a longer time to strategy failure than a late switch (cross-over following RECIST tumor progression).

    Time to strategy failure will be measured from the time of randomization until palbociclib+endocrine therapy discontinuation or death (whichever comes first) - in all randomized patients.

    Measured: From randomization, up to 4 years

  4. Chemotherapy-free survival (Step 2 and 3)

    To assess whether the early switch (following ESR1 mutations increase) to fulvestrant contributes a longer chemotherapy-free survival than a late switch (cross-over following RECIST tumor progression).

    Chemotherapy-free survival will be measured from the time of randomization until the date of chemotherapy initiation or death (whichever comes first) - in all randomized patients.

    Measured: From randomization, up to 4 years

  5. Incidence of treatment-emergent extra-hematological Adverse Events

    To obtain additional safety data in a broad patient population treated with palbociclib and hormone therapy (aromatase inhibitor or fulvestrant) in a general Description of all extra-hematological grade ≥3 toxicities and SAEs incidence rate in the overall population and each treatment step

    Measured: Throughout study completion, up to 4 years

  6. Quality of life by quality of life questionnaire (QLQ)-C30

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: From inclusion and every 2 months until disease progression, up to 2 years

  7. Other line of therapy

    To report the anti-cancer treatments received after the first line therapy.

    Measured: Throughout study completion, up to 4 years

  8. Overall Survival

    The overall survival is the length of time from inclusion that patients enrolled in the study are still alive.

    Measured: Throughout study completion, up to 4 years

Timeline

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

  1. First posted14 Mar 2017
  2. Study start22 Mar 2017
  3. Primary completion30 Apr 2021
  4. Study completion22 Sep 2025

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
Sequential
Model description
Step 1: 1000 patients screened for circulating blood ESR1 mutation detection at regular intervals will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off (28-day cycle) + AI (letrozole, anastrozole or exemestane) administered once daily in a continuous scheme until tumor progression (assessed by RECIST) or ESR1 mutation detection Step 2: Up to 200 Patients with a rising circulating ESR1 mutation and without tumor progression will be randomized (1:1): * ARM A: no change in therapy until tumor progression (RECIST) or possibility of a cross-over (step 3) * ARM B: palbociclib 125 mg + fulvestrant 500 mg administered intramuscularly on D1,15 and 29 and once monthly thereafter until tumor progression (RECIST) * Step 3 (cross over): up to 80 patients who have been randomized in arm A will be offered to be treated by fulvestrant + palbociclib, after having progressed under AI + palbociclib until tumor progression (RECIST) under fulvestrant + palbociclib.
Masking
None (open label)
Enrolment
1,017 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079011
Sponsor's protocol ID
UC-0140/1615 - UCBG3-05
Other IDs
2016-004360-18, 2016
Acronym
PADA-1
Status last verified
Oct 2025
First submitted
9 Feb 2017
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bidard FC, Hardy-Bessard AC, Dalenc F, Bachelot T, Pierga JY, de la Motte Rouge T, Sabatier R, Dubot C, Frenel JS, Ferrero JM, Ladoire S, Levy C, Mouret-Reynier MA, Lortholary A, Grenier J, Chakiba C, Stefani L, Plaza JE, Clatot F, Teixeira L, D'Hondt V, Vegas H, Derbel O, Garnier-Tixidre C, Canon JL, Pistilli B, Andre F, Arnould L, Pradines A, Bieche I, Callens C, Lemonnier J, Berger F, Delaloge S; PADA-1 investigators. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1367-1377. doi: 10.1016/S1470-2045(22)00555-1. Epub 2022 Sep 29.

    PubMed 36183733

  • Berger F, Marce M, Delaloge S, Hardy-Bessard AC, Bachelot T, Bieche I, Pradines A, De La Motte Rouge T, Canon JL, Andre F, Arnould L, Clatot F, Lemonnier J, Marques S, Bidard FC; PADA-1 investigators. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1. BMJ Open. 2022 Mar 3;12(3):e055821. doi: 10.1136/bmjopen-2021-055821.

    PubMed 35241469

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palbociclib 125mg, Aromatase Inhibitors and Fulvestrant Injectable Product in people with Metastatic Breast Cancer, run by UNICANCER at 82 sites in France.

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 30 inclusion and 21 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in France. 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?

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?

Incidence of treatment-emergent Adverse Events (time frame: Throughout study completion, up to 4 years). The study lists 2 primary outcomes in all. 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 NCT03079011, 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 18 Nov 2025.

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