AzTrials
AzTrials

Metastatic Breast CancerPhase 2NCT02238509

Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies

A Phase 2 study testing Lapatinib and Trastuzumab in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 36 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated. 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?
Lapatinib and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
36 sitesItaly
Study dates
Nov 2014to Oct 2017
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

  • Histological or cytological confirmed and documented adenocarcinoma of the breast with metastatic disease
  • The original tumour specimen must be HER2 IHC 3+ positive or, in case of IHC 2+
  • Age ≥18
  • Life expectancy of >12 weeks
  • ECOG PS 0-1
  • Measurable disease as defined by RECIST1.1 criteria
Show all 15Show fewer
  • All patients must have received prior anthracycline-and taxane-based regimens as well as trastuzumab based regimens in either the adjuvant or the metastatic setting. Patients must have been already treated with at least one line of the anti HER2 inhibitor therapy lapatinib for their metastatic breast cancer. A maximum of three previous lines of anti-HER-2 therapies in the metastatic setting are allowed.
  • Adequate haematological function as defined by: ANC 1.5 x 109/L, platelet count 100 x 109/L, haemoglobin 10 g/dL.
  • Adequate renal function, as defined by: creatinine 1.5 x UNL
  • Adequate hepatobiliary function, as defined by the following baseline liver function tests: total serum bilirubin 1.5 upper normal limit (UNL); alanine amino transferase (ALT), aspartate amino transferase (AST) 2.5xUNL; alkaline phosphatase (AP) 2.5xUNL; if total alkaline phosphatase (AP) > 2.5xUNL, alkaline phosphatase liver fraction must be 2.5xUNL
  • Adequate contraception for all fertile patients
  • Negative pregnancy test.
  • Postmenopausal women fulfilling any of the NCCN criteria may be included.
  • Left ventricular ejection fraction (LVEF) ≥50% during a baseline period of 28 days, as determined by either echocardiography (ECHO) or multi gated acquisition (MUGA) scan.
  • Signed, written informed consent

Who cannot join

  • History of persistent Grade ≥ 2 hematologic toxicity resulting from previous systemic therapy
  • Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
  • History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Bone-only disease, unless a measurable lesion is evident as determined by RECIST v1.1
  • Bone scan, PET scan or plain films are not considered adequate imaging techniques to measure bone lesions. ve
  • Blastic bone lesions are non-measurable.
Show all 18Show fewer
  • Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease.
  • Current dyspnoea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy.
  • Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization.
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
  • History of receiving any investigational treatment within 28 days of randomization
  • Current known infection with HIV, HBV, or HCV
  • Receipt of IV antibiotics for infection within 14 days of randomization
  • Known hypersensitivity to any of the study drugs
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  • Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
  • Concurrent interventional or non-interventional studies

Trial locations and contacts

36 sites in 1 country.

Clinical Research Technology contact

0039089301545

36 sites in 1 country

Italy36 sites, 36 recruiting

  • A.O.U. Ospedali Riuniti Umberto I

    Ancona, 60020

    Stefano Cascinu, MD

    Stefano Cascinu, MD

    Not yet recruiting

  • Centro di Riferimento Oncologico

    Aviano, 33081

    Simon Spazzapan, MD

    Simon Spazzapan, Md

    Recruiting

  • Policlinico S. Orsola Malpighi

    Bologna, MD

    Claudio Zamagni, MD

    Claudio Zamagni, MD

    Not yet recruiting

  • Ospedale Centrale di Bolzano

    Bolzano, 39100

    Elisabetta Cretella, MD

    Elisabetta Cretella, MD

    Not yet recruiting

  • Presidio Ospedaliero 'Antonio Perrino

    Brindisi, 72100

    Saverio Cinieri, MD

    Saverio Cinieri, MD

    Recruiting

  • A.O.R.N.A.S. Garibaldi Nesima di Catania

    Catania, 95122

    Roberto Bordonaro, MD

    Roberto Bordonaro, MD

    Recruiting

  • Humanitas Centro Catanese di Oncologia

    Catania, 95126

    Michele Caruso, MD

    Michele Caruso, MD

    Not yet recruiting

  • Azienda Ospedaliera S. Anna

    Como, 22100

    Monica Giordano, MD

    Monica Giordano, MD

    Not yet recruiting

  • Ospedale 'F. Spaziani'

    Frosinone, 03100

    Teresa Gamucci, MD

    Teresa Gamucci, MD

    Not yet recruiting

  • I.R.C.C.S. A.O.U. San Martino

    Genova, 16132

    Lucia Del Mastro, MD

    Lucia Del Mastro, MD

    Not yet recruiting

  • Ospedale Civile di Guastalla

    Guastalla, 42016

    Laura Scaltriti, Md

    Laura Scaltriti, Md

    Not yet recruiting

  • Ospedale Vito Fazzi

    Lecce, 73100

    Mariangela Ciccarese, MD

    Mariangela Ciccarese, MD

    Recruiting

  • Ospedale di Lugo - AUSL della Romagna

    Lugo, 48022

    Michele Gianni Turolla, MD

    Michele Gianni Turolla, Md

    Not yet recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

    Dino Amadori, MD

    Dino Amadori, MD

    Not yet recruiting

  • Ospedale Niguarda Ca' Granda

    Milan, 20162

    Salvatore Siena, Md

    Salvatore Siena, Md

    Not yet recruiting

  • A.O. San Gerardo

    Monza, 20900

    Marina Elena Cazzaniga, MD, 039-233.3683, ricercaindipendente.monza@gmail.com

    Marina Elena Cazzaniga, MD

    Recruiting

  • Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"

    Naples, 8011

    Michele De Laurentiis, MD

    Michele De Laurentiis, MD

    Recruiting

  • AORN "A. Cardarelli"

    Naples, 80131

    Nando Riccardi, MD, 08174721740, nando.riccardi@alice.it

    Recruiting

  • Policlinico SUN

    Naples, 80131

    Michele Orditura, MD

    Michele Orditura, MD

    Not yet recruiting

  • Università degli Studi di Napoli "Federico II"

    Naples, 80131

    Grazia Arpino, MD

    Grazia Arpino, MD

    Recruiting

  • A.R.N.A.S. Ospedale Civico e Benfratelli

    Palermo, 90127

    Vita Leonardi, MD

    Vita Leonardi, MD

    Recruiting

  • Ospedale S. Maria della Misericordia

    Perugia, 06156

    Anna Maria Mosconi, MD

    Anna Maria Mosconi, MD

    Recruiting

  • Azienda Ospedaliera Santa Maria degli Angeli

    Pordenone, 33170

    Silvana Saracchini, MD

    Silvana Saracchini, MD

    Not yet recruiting

  • Ospedale di Ravenna

    Ravenna, 48100

    Claudio Dazzi, MD

    Dazzi Claudio, MD

    Not yet recruiting

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, 42123

    Corrado Boni, MD

    Corrado Boni, MD

    Not yet recruiting

  • Ospedale Infermi di Rimini

    Rimini, 47923

    Lorenzo Gianni, MD

    Lorenzo Gianni, MD

    Not yet recruiting

  • Policlinico Universitario Campus Biomedico

    Roma, 00128

    Giuseppe Tonini, Md

    Giuseppe Tonini, MD

    Recruiting

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, 00144

    Francesco Cognetti, Md

    Cognetti Francesco, MD

    Recruiting

  • Ospedale G. Da Procida

    Salerno, 84126

    Maria Luisa Barzelloni, MD

    Maria Luisa Barzelloni, MD

    Not yet recruiting

  • Ospedale Civile di Sassari SS Annunaziata

    Sassari, 07100

    Nina Olmeo, MD

    Nina Olmeo, MD

    Recruiting

  • Ospedale 'SS. Trinità'

    Sora, 03039

    Teresa Gamucci, MD

    Teresa Gamucci, MD

    Recruiting

  • Azienda Ospedaliera S.Maria di Terni

    Terni, 05100

    Fauso Roila, Md

    Fausto Roila, MD

    Recruiting

  • A.O.U. San Giovanni Battista di Torino

    Torino, 10126

    Mario Airoldi, MD

    Mario Airoldi, MD

    Not yet recruiting

  • A.O.U. Santa Maria della Misericordia di Udine

    Udine, 33100

    fabio Puglisi, MD

    Fabio Puglisi, MD

    Recruiting

  • A.O. Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

    Giovanni Giardina, MD

    Giovanni Giardina, MD

    Not yet recruiting

  • Ospedale Sacro Cuore Don Calabria

    Verona, 37024

    Stefania Gori, MD

    Stefania Gori, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: A Randomised, Multicentre, Open-label Phase II Trial Investigating Activity of Chemotherapy and Lapatinib and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer (MBC) Refractory to Anti HER2 Therapies

Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated. According to this evidence, the combination of lapatinib and trastuzumab today offers a valid chemotherapy-free option, primarily for patients with pre-treated HER2-positive MBC

Read the detailed description

The present study is designed to determine the efficacy and safety profile of the combination of lapatinib and trastuzumab (plus endocrinetherapy in ER-positive breast cancer) versus trastuzumab and chemotherapy in heavily pretreated patient population with HER2-positive MBC and to investigate the predictive role of cfDNA for detection of HER2 gene amplification on patients' outcome. The presence of circulating free DNA (cfDNA) for detection of HER2 gene amplification was associated with worse prognosis and seems to allow early response evaluation. However, many aspects of the role of cfDNA detection in patients undergoing molecular target agents such as trastuzumab or lapatinib are not well described. With the availability of improved and standardized techniques for cfDNA detection, it should now be possible to examine several of these important questions within a prospective multicenter study and a striking potential of cfDNA for detection of HER2 gene amplification might enable a more individual and optimized antimetastatic therapy inpatients with cancer.

Being tested
Lapatinib, Trastuzumab
Keywords
Breast cancer, HER2 Positive, HER2+, MBC, Metastatic, Metastatic breast cancer, Chemotherapy, Lapatinib, Trastuzumab, anti HER2 therapies
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • LapatinibDrug

    Also called Tyverb

    ARM A: oral lapatinib 1,000 mg daily in combination with intravenous trastuzumab 6mg/kg q3wks (after the initial 8 mg/kg loading dose).

  • TrastuzumabDrug

    Also called Herceptin

    ARM A: oral lapatinib 1,000 mg daily in combination with intravenous trastuzumab 6mg/kg q3wks (after the initial 8 mg/kg loading dose).

Study groups in NCT02238509
Study groupRoleWhat they receive
lapatinib and trastuzumabExperimentalARM A: Lapatinib and trastuzumab (experimental arm). Patients with hormone receptor (HR) positive breast cancer will also receive endocrine therapy at the physician's discretion (preferred choice with fulvestrant).
Receives: Drug: Lapatinib; Drug: Trastuzumab
trastuzumab plus chemotherapyExperimentalARM B: Trastuzumab plus chemotherapy (control arm). Any type of chemotherapy in combination with trastuzumab will be allowed at the physician's discretion.
Receives: Drug: Trastuzumab

What is being measured

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

  1. Clinical Benefit Rate

    To evaluate clinical benefit rate (CBR) for patients treated with lapatinib and trastuzumab and for patients treated with trastuzumab and chemotherapy. CBR is defined as: confirmed complete response (CR) plus partial response (PR) at any time, plus stable disease (SD) for 24 weeks

    Measured: Clinical Benefit Rate is defined as confirmed complete response plus partial response at any time, plus stable disease up to 24 weeks

Secondary outcomes (4)

  1. Progression free survival

    Second-line progression-free survival, defined as the time from first dosing to the first documented disease progression or death from any cause, whichever occurs first.

    Measured: Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 36 months

  2. Overall Survival

    OS is defined as the time from first dosing in second line to death from any cause.

    Measured: Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 36 months

  3. Safety and tolerability

    Safety of second line treatment will be evaluated by the frequency of AEs and SAEs, cardiac events, clinically significant abnormal laboratory tests, vital signs, and ECOG PS. All patients who received at least one dose of study treatment will be included in the safety analysis.

    Measured: Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 36 months

  4. Quality of life

    QoL and symptom control will be assessed using the FACT-B questionnaire.

    Measured: Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 36 months

Timeline

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

  1. First posted12 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02238509
Sponsor's protocol ID
GIM12-TYPHER
Other IDs
2013-005044-29
Status last verified
Jun 2016
First submitted
9 Sep 2014
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Nahta R, Esteva FJ. Herceptin: mechanisms of action and resistance. Cancer Lett. 2006 Feb 8;232(2):123-38. doi: 10.1016/j.canlet.2005.01.041.

    PubMed 16458110

  • Nahta R, Yu D, Hung MC, Hortobagyi GN, Esteva FJ. Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat Clin Pract Oncol. 2006 May;3(5):269-80. doi: 10.1038/ncponc0509.

    PubMed 16683005

  • Jagiello-Gruszfeld A, Tjulandin S, Dobrovolskaya N, Manikhas A, Pienkowski T, DeSilvio M, Ridderheim M, Abbey R. A single-arm phase II trial of first-line paclitaxel in combination with lapatinib in HER2-overexpressing metastatic breast cancer. Oncology. 2010;79(1-2):129-35. doi: 10.1159/000318043. Epub 2010 Nov 22.

    PubMed 21088439

  • Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006 Dec 28;355(26):2733-43. doi: 10.1056/NEJMoa064320.

    PubMed 17192538

  • Clemens M, Eidtmann H, Nitz U, Niederle N, du Bois A, Grischke EM, Hinke A, von Minckwitz G. Trastuzumab single-drug therapy after failure of cytotoxic treatment for metastatic breast cancer. Onkologie. 2010;33(8-9):425-30. doi: 10.1159/000318144. Epub 2010 Jul 27.

    PubMed 20838057

  • von Minckwitz G, Schwedler K, Schmidt M, Barinoff J, Mundhenke C, Cufer T, Maartense E, de Jongh FE, Baumann KH, Bischoff J, Harbeck N, Luck HJ, Maass N, Zielinski C, Andersson M, Stein RC, Nekljudova V, Loibl S; GBG 26/BIG 03-05 study group and participating investigators. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur J Cancer. 2011 Oct;47(15):2273-81. doi: 10.1016/j.ejca.2011.06.021. Epub 2011 Jul 7.

    PubMed 21741829

  • Blackwell KL, Burstein HJ, Storniolo AM, Rugo H, Sledge G, Koehler M, Ellis C, Casey M, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Randomized study of Lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1124-30. doi: 10.1200/JCO.2008.21.4437. Epub 2010 Feb 1.

    PubMed 20124187

  • Wu Y, Amonkar MM, Sherrill BH, O'Shaughnessy J, Ellis C, Baselga J, Blackwell KL, Burstein HJ. Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer. Ann Oncol. 2011 Dec;22(12):2582-2590. doi: 10.1093/annonc/mdr014. Epub 2011 Mar 15.

    PubMed 21406472

  • Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

    PubMed 19786658

  • Page K, Hava N, Ward B, Brown J, Guttery DS, Ruangpratheep C, Blighe K, Sharma A, Walker RA, Coombes RC, Shaw JA. Detection of HER2 amplification in circulating free DNA in patients with breast cancer. Br J Cancer. 2011 Apr 12;104(8):1342-8. doi: 10.1038/bjc.2011.89. Epub 2011 Mar 22.

    PubMed 21427727

  • Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84. doi: 10.1056/NEJMoa052122.

    PubMed 16236738

  • Wang YC, Morrison G, Gillihan R, Guo J, Ward RM, Fu X, Botero MF, Healy NA, Hilsenbeck SG, Phillips GL, Chamness GC, Rimawi MF, Osborne CK, Schiff R. Different mechanisms for resistance to trastuzumab versus lapatinib in HER2-positive breast cancers--role of estrogen receptor and HER2 reactivation. Breast Cancer Res. 2011;13(6):R121. doi: 10.1186/bcr3067. Epub 2011 Nov 28.

    PubMed 22123186

  • Tan-Chiu E, Yothers G, Romond E, Geyer CE Jr, Ewer M, Keefe D, Shannon RP, Swain SM, Brown A, Fehrenbacher L, Vogel VG, Seay TE, Rastogi P, Mamounas EP, Wolmark N, Bryant J. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol. 2005 Nov 1;23(31):7811-9. doi: 10.1200/JCO.2005.02.4091.

    PubMed 16258083

  • Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.

    PubMed 11248153

  • Rusnak DW, Lackey K, Affleck K, Wood ER, Alligood KJ, Rhodes N, Keith BR, Murray DM, Knight WB, Mullin RJ, Gilmer TM. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol Cancer Ther. 2001 Dec;1(2):85-94.

    PubMed 12467226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib and Trastuzumab in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 36 sites in Italy.

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 15 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clinical Research Technology (0039089301545), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (time frame: Clinical Benefit Rate is defined as confirmed complete response plus partial response at any time, plus stable disease up to 24 weeks). 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 NCT02238509, which also lists 15 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 15 Jun 2016.

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