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Advanced Breast CancerPhase 2NCT00777101

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

A Phase 2 study testing Neratinib, Lapatinib and Capecitabine in people with Advanced Breast Cancer and Breast Cancer, run by Puma Biotechnology, Inc. at 152 sites in 31 countries.

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 is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer, Breast Cancer
What is being tested?
Neratinib, Lapatinib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
152 sitesin 31 countries
Study dates
4 Feb 2009to 3 Jun 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  • Prior use of Herceptin (trastuzumab), and a taxane
  • Adequate cardiac and renal function

Who cannot join

  • More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  • Bone as the only site of disease
  • Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  • Significant gastrointestinal disorder with diarrhea as major symptom

Trial locations and contacts

152 sites in 31 countries.

152 sites in 31 countries

United States44 sites

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • Texas Oncology, P.A.

    Austin, Texas, 78731-4214

  • Palm Beach Institute of Hematology & Oncology

    Boynton Beach, Florida, 33435

  • Oncology Partners Network

    Cincinnati, Ohio, 45247

  • MetroHealth Medical Center, Cancer Care Center

    Cleveland, Ohio, 44109

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Cancer Care Specialists Of Central Illinois

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80220

  • El Paso Cancer Treatment Center - West

    El Paso, Texas, 79902

  • Central Indiana Cancer Centers

    Fishers, Indiana, 46037

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Robert R. Carroll, MD, PA

    Gainesville, Florida, 32605

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260-2082

  • University of Florida

    Jacksonville, Florida, 32209

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Center for Biomedical Research

    Knoxville, Tennessee, 37909

  • Thompson Cancer Survival Center Thompson Oncology Group

    Knoxville, Tennessee, 37916

  • Arena Oncology Associates, PC

    Lake Success, New York, 11042

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17605

  • Owsley Brown Frazier Cancer Center (OBFCC)

    Louisville, Kentucky, 40245

  • Hematology Oncology Associates

    Loxahatchee Groves, Florida, 33470

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • Mercy Research Institute

    Miami, Florida, 33133

  • Southwest Cancer Care

    Murrieta, California, 92562

  • Floyd Memorial Cancer Center of Indiana

    New Albany, Indiana, 47150

  • Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center Dept. of Hematology Oncology

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Medical Center

    Orange, California, 92868-3298

  • Cancer Centers of Florida

    Orlando, Florida, 32806

  • Purchase Cancer Group

    Paducah, Kentucky, 42001

  • Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • Allegheny General Hospital Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • HOPE Oncology

    Richardson, Texas, 75080

  • Cancer Care Network of South Texas-HOAST

    San Antonio, Texas, 78229

  • Redwood Regional Medical Group, Inc.

    Santa Rosa, California, 95403

  • Hematology Oncology Associates, P.C.

    Stamford, Connecticut, 06902

  • New York Oncology Hematolgy, PC

    Troy, New York, 12180

  • Arizona Oncology Associates HOPE

    Tucson, Arizona, 85704-7891

  • East Texas Medical Center Cancer Institute, Tyler Hematology Oncology

    Tyler, Texas, 75701-2043

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Japan20 sites

  • Aichi Cancer Center

    Aichi

  • Chiba Cancer Center

    Chiba

  • National Cancer Center Hospital East

    Chiba

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka

  • Hiroshima City Hospital

    Hiroshima

  • Hyogo Cancer Center

    Hyōgo

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima

  • Tokai University Hospital

    Kanagawa

  • Kumamoto Municipal Hospital

    Kumamoto

  • Kyoto University Hospital

    Kyoto

  • Niigata Cancer Center Hospital

    Niigata

  • National Hospital Organization Osaka National Hospital

    Osaka

  • Saitama Cancer Center

    Saitama

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido

  • Shizuoka Cancer Center

    Shizuoka

  • Jichi Medical University Hospital

    Tochigi

  • St. Luke's International Hospital

    Tokyo

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology

    Tokyo

  • Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp

    Tokyo

  • National Cancer Center Hospital

    Tsukiji, Tokyo

Other trials in Japan

Spain15 sites

  • Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia

    A Coruña, 15006

  • Hospital General Universitario de Alicante Servicio de Oncologia

    Alicante, 03010

  • Hospital Germans Trias i Pujol Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital San Pedro de Alcantara Servicio de Oncologia

    Cáceres, 10003

  • Hospital Provincial (Reina Sofia) Servicio de Oncologia

    Córdoba, 14004

  • Hospital Universitario Dr. Josep Trueta Servicio de Oncologia

    Girona, 17007

  • Centro Hospitalario de Jaen Servicio de Oncologia

    Jaén, 23007

  • Hospital Gregorio Marañon Servicio de Oncologia

    Madrid, 28007

  • Centro Oncologico M.D. Anderson Internacional

    Madrid, 28033

  • Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal

    Oviedo, Principality of Asturias, 33006

  • Corporacio Sanitaria Parc Tauli Servicio de Oncologia

    Sabadell, Barcelona, 08208

  • Hospital Mutua de Terrassa Servicio de Oncologia

    Terrassa, Barcelona, 08221

  • Instituto Valenciano de Oncologia Servicio de Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia

    Valencia, 46010

  • Hospital Universitario Miguel Servet Servicio de Oncologia

    Zaragoza, 50009

Other trials in Spain

Russia9 sites

  • Russian Oncology Research Centre of RAMS

    Moscow, 115478

  • GUZ Perm Regional Oncology Dispensary

    Perm, 614066

  • Scientific Research Institute of Oncology N.N. Petrov

    Pesochny, Sankt-Peterburg, 197758

  • Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development

    Ryazan, 390011

  • SIH Leningrad Regional Oncology Dispensary

    Saint Petersburg, 191104

  • GUZ City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • St. Petersburg State Medical University I.P.Pavlov of Roszdrav

    Saint Petersburg, 197022

  • SIH Oncology Dispensary # 2 Of Department of Public Health

    Sochi, 354057

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic

    Ufa, 450054

Other trials in Russia

Hungary6 sites

  • Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia

    Budapest, 1032

  • Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

    Budapest, 1122

  • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

    Kecskemét, 6000

  • Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem Onkoterapias Klinika

    Szeged, 6720

  • Hospital of County Veszprem

    Veszprém, 8200

Other trials in Hungary

Australia4 sites

  • Medical Oncology Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Western Hospital

    Footscray, Victoria, 3011

  • Mater Private Centre for HOCA

    South Brisbane, Queensland, 4101

  • Mount Hospital

    West Perth, 6000

Other trials in Australia

France4 sites

  • Centre Oscar Lambret Departement de senologie

    Lille, 59020

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69340

  • CHU de Poitiers Service d'oncologie medicale

    Poitiers, 86021

  • Institut Gustave ROUSSY Service de Pathologie mammaire

    Villejuif, 94805

Other trials in France

Poland4 sites

  • Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii

    Gdansk, 80952

  • Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii

    Krakow, 31-531

  • Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli

    Lublin, 20-090

Other trials in Poland

Romania4 sites

  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

    Bucharest, 022328

  • Spitalul Universitar de Urgenta

    Bucharest, 050098

  • Centrul de Oncologie Medicala

    Iași, 700106

  • Spitalul Clinic Judetean

    Sibiu, 550245

Other trials in Romania

South Africa4 sites

  • Hopelands Oncology Centre

    Durban, KwaZulu-Natal, 4001

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • GVI Oncology Trial Unit Room 110 Panorama Medical Centre

    Kraaifontein, Western Cape

  • Eastleigh Breast Care Centre

    Lynnwood, Gauteng, 0081

Other trials in South Africa

South Korea4 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Yonsei University Health System - Severance Hospital

    Seoul, 120-752

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Bulgaria3 sites

  • District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy

    Sofia, 1233

  • UMHAT Tzaritza Yoanna

    Sofia, 1527

  • Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care

    Varna, 9000

Other trials in Bulgaria

Croatia3 sites

  • General Hospital Varazdin

    Varaždin, 42000

  • University Hospital Center Zagreb

    Zagreb, 10000

  • University Hospital Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Hong Kong3 sites

  • Department of Clinical Oncology, Tuen Mun Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

    Hong Kong

Other trials in Hong Kong

Switzerland3 sites

  • University of Lausanne Hospitals CHUV

    Lausanne, 1011

  • Kantonsspital Winterthur Medizinische Onkologie

    Winterthur, 8401

  • Abteilung fuer Onkologie Departement für Innere

    Zurich, CH-8091

Other trials in Switzerland

United Kingdom3 sites

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • Royal Marsden NHS Foundation Trust & Institute of Cancer Research

    London, SW3 6JJ

  • The Royal Marsden NHS Foundation Trust & Institute of Cancer Research

    London, SW3 6JJ

Other trials in United Kingdom

Canada2 sites

  • Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

    Québec, Quebec, G1S 4L8

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany2 sites

  • Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie

    Hamburg, 20246

  • Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie

    Heidelberg, 69120

Other trials in Germany

Italy2 sites

  • Ospedale Misericordia e Dolce c/o UO Oncologia Medica

    Prato, 59100

  • Istituto Regina Elena, Struttura Complessa Oncologia Medica A

    Roma, 00144

Other trials in Italy

Serbia2 sites

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

  • Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))

    Belgrade, 11000

Other trials in Serbia

Austria1 site

  • AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie

    Vienna, A-1090

Other trials in Austria

Belgium1 site

  • Institut Jules Bordet Unite du Chimiotherapie

    Brussels, 1000

Other trials in Belgium

Czechia1 site

  • Fakultni nemocnice Olomouc Klinika onkologie

    Olomouc, 775 20

Other trials in Czechia

Greece1 site

  • Theagenio Anticancer Hospital of Thessaloniki

    Thessaloniki, 54007

Other trials in Greece

Jordan1 site

  • King Hussein Cancer Centre

    Amman, 11941

Other trials in Jordan

Mexico1 site

  • Oca Hospital / Monterrey International Research Center

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Puerto Rico1 site

  • Metropolitan Oncology Center

    San Juan, PR, 00910

Other trials in Puerto Rico

Singapore1 site

  • Johns Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Slovenia1 site

  • Institute for Oncology Department for Medical Oncology

    Ljubljana, 1000

Other trials in Slovenia

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Thailand1 site

  • Division of Medical Oncology, Department of Medicine

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Being tested
Neratinib, Lapatinib, Capecitabine
Keywords
HER2, ErbB2, metastatic, neratinib, lapatinib, capecitabine, HKI-272, Nerlynx, PB-272
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.

  • NeratinibDrug

    Also called HKI-272

    Tablets 240 mg orally once per day until disease progression or unacceptable toxicity

  • LapatinibDrug

    Also called Tykerb, Tyverb

    Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.

  • CapecitabineDrug

    Also called Xeloda

    Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Study groups in NCT00777101
Study groupRoleWhat they receive
NeratinibExperimentalNot described
Receives: Drug: Neratinib
Lapatinib plus CapecitabineActive comparatorNot described
Receives: Drug: Lapatinib; Drug: Capecitabine

What is being measured

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

  1. Progression Free Survival

    Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.

    Measured: From randomization date to progression or death, assessed up to 69 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.

    Measured: From randomization date to death, assessed up to 69 months

  2. Objective Response Rate (ORR).

    Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.

    Measured: From randomization date to progression or last tumor assessment, assessed up to 69 months

  3. Clinical Benefit Rate

    Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Clinical Benefit (CB) = CR + PR + SD >= 24 weeks.

    Measured: From randomization date to progression or last tumor assessment, assessed up to 69 months

  4. Duration of Response

    Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: From start date of response to first PD, assessed up to 69 months after the first subject was randomized.

  5. Frequency of CNS Metastases (Frequency)

    The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.

    Measured: From randomization date to first CNS symptom or lesions

  6. Time to CNS Metastases

    Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).

    Measured: From randomization date to first CNS symptom or lesions

Timeline

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

  1. First posted22 Oct 2008 (estimated)
  2. Study start4 Feb 2009
  3. Primary completionMar 2011
  4. Study completion3 Jun 2018

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
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00777101
Sponsor's protocol ID
3144A2-3003 / B1891003
Status last verified
Jul 2018
First submitted
21 Oct 2008
Last updated
9 Aug 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.

    PubMed 23953056

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neratinib, Lapatinib and Capecitabine in people with Advanced Breast Cancer and Breast Cancer, run by Puma Biotechnology, Inc. at 152 sites in 31 countries.

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 3 inclusion and 4 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Japan, Spain, Russia, Hungary and 26 more countries. 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?

Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: From randomization date to progression or death, assessed up to 69 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 NCT00777101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.

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