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Breast NeoplasmsPhase 3TEAMNCT00036270

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

A Phase 3 study testing exemestane (Aromasin) and tamoxifen + exemestane in people with Breast Neoplasms, run by Pfizer at 179 sites in United States.

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

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
exemestane (Aromasin) and tamoxifen + exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,779 participants
Where
179 sitesUnited States
Study dates
Aug 2001to Feb 2011
Phase
Phase 3
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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
  • Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Who cannot join

  • Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
  • Inflammatory breast cancer
  • Histologically positive supraclavicular nodes
  • Ulceration/infiltration of local skin metastasis
  • Neoadjuvant chemotherapy
  • Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
  • ER and PR negative primary tumor or ER/PR unknown status.

Trial locations and contacts

179 sites in 1 country.

179 sites in 1 country

United States179 sites

  • Pfizer Investigational Site

    Abilene, Texas, 79606-5208

  • Pfizer Investigational Site

    Albany, New York, 12206

  • Pfizer Investigational Site

    Albany, New York, 12208

  • Pfizer Investigational Site

    Alton, Illinois, 62002

  • Pfizer Investigational Site

    Amsterdam, New York, 12010

  • Pfizer Investigational Site

    Arlington, Texas, 76012

  • Pfizer Investigational Site

    Arlington, Texas, 76014

  • Pfizer Investigational Site

    Arlington Heights, Illinois, �60005

  • Pfizer Investigational Site

    Asheville, North Carolina, 28801

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Austin, Texas, 78731

  • Pfizer Investigational Site

    Austin, Texas, 78745

  • Pfizer Investigational Site

    Bartlesville, Oklahoma, 74006

  • Pfizer Investigational Site

    Beaumont, Texas, 77702-1449

  • Pfizer Investigational Site

    Bedford, Texas, 76022'

  • Pfizer Investigational Site

    Bessemer, Alabama, 35022

  • Pfizer Investigational Site

    Birmingham, Alabama, 35205

  • Pfizer Investigational Site

    Birmingham, Alabama, 35209

  • Pfizer Investigational Site

    Birmingham, Alabama, 35211

  • Pfizer Investigational Site

    Birmingham, Alabama, 35213

  • Pfizer Investigational Site

    Birmingham, Alabama, 35235

  • Pfizer Investigational Site

    Boulder, Colorado, 80303

  • Pfizer Investigational Site

    Brockport, New York, 14420

  • Pfizer Investigational Site

    Burien, Washington, 98166

  • Pfizer Investigational Site

    Burnsville, Minnesota, 55337

  • Pfizer Investigational Site

    Canandaigua, New York, 14424

  • Pfizer Investigational Site

    Carmel, Indiana, 46032

  • Pfizer Investigational Site

    Cary, North Carolina, 27518

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52403

  • Pfizer Investigational Site

    Chesapeake, Virginia, 23320

  • Pfizer Investigational Site

    Christianburg, Virginia, 24073

  • Pfizer Investigational Site

    Christianburg,, Virginia, 24073

  • Pfizer Investigational Site

    Clearwater, Florida, 33761

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Columbia, Missouri, 65201

  • Pfizer Investigational Site

    Dallas, Texas, 75230-2510

  • Pfizer Investigational Site

    Dallas, Texas, 75231-4400

  • Pfizer Investigational Site

    Dallas, Texas, 75237

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Denton, Texas, 76210

  • Pfizer Investigational Site

    Denver, Colorado, 80218

  • Pfizer Investigational Site

    Denver, Colorado, 80220

  • Pfizer Investigational Site

    Durham, North Carolina, 27704

  • Pfizer Investigational Site

    Easley, South Carolina, 29640

  • Pfizer Investigational Site

    Edina, Minnesota, 55435-2150

  • Pfizer Investigational Site

    Edmonds, Washington, 98026

  • Pfizer Investigational Site

    El Paso, Texas, 79902

  • Pfizer Investigational Site

    El Paso, Texas, 79915

  • Pfizer Investigational Site

    Elizabeth City, North Carolina, 27909

  • Pfizer Investigational Site

    Eugene, Oregon, 97401

  • Pfizer Investigational Site

    Fairfax, Virginia, 22031

  • Pfizer Investigational Site

    Fishers, Indiana, 46037

  • Pfizer Investigational Site

    Flagstaff, Arizona, 86001

  • Pfizer Investigational Site

    Fort Collins, Colorado, *0524

  • Pfizer Investigational Site

    Fort Worth, Texas, 76104

  • Pfizer Investigational Site

    Fredericksburg, Texas, 78624

  • Pfizer Investigational Site

    Gainesville, Virginia, 20155

  • Pfizer Investigational Site

    Garland, Texas, 75042

  • Pfizer Investigational Site

    Geneva, New York, 14456

  • Pfizer Investigational Site

    Green Valley, Arizona, 85614

  • Pfizer Investigational Site

    Greenfield, Indiana, 46140

  • Pfizer Investigational Site

    Greenville, South Carolina, 29605

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615

  • Pfizer Investigational Site

    Hampton, Virginia, 23666

  • Pfizer Investigational Site

    Hickory, North Carolina, 28602

  • Pfizer Investigational Site

    Houston, Texas, 77024

  • Pfizer Investigational Site

    Hudson, Florida, 34667

  • Pfizer Investigational Site

    Hudson, New York, 12534

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46219

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46227

  • Pfizer Investigational Site

    Irving, Texas, 75061-224

  • Pfizer Investigational Site

    Jacksonville, Florida, 32204

  • Pfizer Investigational Site

    Jacksonville, Florida, 32207

  • Pfizer Investigational Site

    Kansas City, Kansas, 66112

  • Pfizer Investigational Site

    Kansas City, Missouri, 64111

  • Pfizer Investigational Site

    Kansas City, Missouri, 64131

  • Pfizer Investigational Site

    Kansas City, Missouri, 64154

  • Pfizer Investigational Site

    Kernersville, North Carolina, 27284

  • Pfizer Investigational Site

    Kerrville, Texas, 78028

  • Pfizer Investigational Site

    Kettering, Ohio, 45409

  • Pfizer Investigational Site

    Kingston, Pennsylvania, 18704-5535

  • Pfizer Investigational Site

    Lakewood, Colorado, 80228

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89128

  • Pfizer Investigational Site

    Latham, New York, 12110-0610

  • Pfizer Investigational Site

    Lauderhill, Florida, 33319

  • Pfizer Investigational Site

    Lee's Summit, Missouri, 29307

  • Pfizer Investigational Site

    Lee's Summit, Missouri, 64064

  • Pfizer Investigational Site

    Lewisville, Texas, 75067

  • Pfizer Investigational Site

    Lexington, North Carolina, 27295

  • Pfizer Investigational Site

    Lone Tree, Colorado, 80124

  • Pfizer Investigational Site

    Longmont, Colorado, 80501

  • Pfizer Investigational Site

    Longview, Texas, 75601

  • Pfizer Investigational Site

    Maplewood, Minnesota, 55109

  • Pfizer Investigational Site

    McAllen, Texas, 78503

  • Pfizer Investigational Site

    Melbourne, Florida, 32901

  • Pfizer Investigational Site

    Mesquite, Texas, 75150

  • Pfizer Investigational Site

    Midland, Texas, 79701

  • Pfizer Investigational Site

    New Braunfels, Texas, 78130

  • Pfizer Investigational Site

    New Port Richey, Florida, 34655

  • Pfizer Investigational Site

    Newport News, Virginia, 23606

  • Pfizer Investigational Site

    Niles, Illinois, 60714

  • Pfizer Investigational Site

    Norfolk, Virginia, 23502

  • Pfizer Investigational Site

    Norman, Oklahoma, 73071

  • Pfizer Investigational Site

    North Adams, Massachusetts, 01247

  • Pfizer Investigational Site

    North Little Rock, Arkansas, 72117

  • Pfizer Investigational Site

    Ocala, Florida, 34474

  • Pfizer Investigational Site

    Odessa, Texas, 79761

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73104-5020

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73109

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112-4416

  • Pfizer Investigational Site

    Orange Park, Florida, 32073

  • Pfizer Investigational Site

    Oro Valley, Arizona, 85737

  • Pfizer Investigational Site

    Palatka, Florida, 32177

  • Pfizer Investigational Site

    Paris, Texas, 75460-5004

  • Pfizer Investigational Site

    Phoenix, Arizona, 85012

  • Pfizer Investigational Site

    Pittsfield, Massachusetts, 01201

  • Pfizer Investigational Site

    Plano, Texas, 75075-7787

  • Pfizer Investigational Site

    Plantation, Florida, 33324

  • Pfizer Investigational Site

    Portland, Oregon, 97210

  • Pfizer Investigational Site

    Portland, Oregon, 97213-2996

  • Pfizer Investigational Site

    Portland, Oregon, 97216

  • Pfizer Investigational Site

    Portland, Oregon, 97225

  • Pfizer Investigational Site

    Pueblo, Colorado, 81008

  • Pfizer Investigational Site

    Pulaski, Virginia, 24301

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27607

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27614

  • Pfizer Investigational Site

    Rexford, New York, 12148

  • Pfizer Investigational Site

    Roanoke, Virginia, 24101

  • Pfizer Investigational Site

    Round Rock, Texas, 78681

  • Pfizer Investigational Site

    Safford, Arizona, 85546

  • Pfizer Investigational Site

    Saint Augustine, Florida, 32086

  • Pfizer Investigational Site

    Saint Paul, Minnesota, 55102-2389

  • Pfizer Investigational Site

    Salem, Virginia, 24153

  • Pfizer Investigational Site

    San Antonio, Texas, 78212

  • Pfizer Investigational Site

    San Antonio, Texas, 78217

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Antonio, Texas, 78258-3912

  • Pfizer Investigational Site

    Santa Fe, New Mexico, 87505

  • Pfizer Investigational Site

    Scottsdale, Arizona, 85258

  • Pfizer Investigational Site

    Seattle, Washington, 98133-8414

  • Pfizer Investigational Site

    Seattle, Washington, 98133

  • Pfizer Investigational Site

    Sedona, Arizona, 86336

  • Pfizer Investigational Site

    Seneca, North Carolina, 29672

  • Pfizer Investigational Site

    Shawnee Mission, Kansas, 66204

  • Pfizer Investigational Site

    Shelbyville, Indiana, 46176

  • Pfizer Investigational Site

    Sherman, Texas, TX 75090-0504

  • Pfizer Investigational Site

    Spartanburg, South Carolina, 29307

  • Pfizer Investigational Site

    Spokane, Washington, 99202

  • Pfizer Investigational Site

    Spokane, Washington, 99216

  • Pfizer Investigational Site

    Spokane, Washington, 99218

  • Pfizer Investigational Site

    Springfield, Oregon, 97477

  • Pfizer Investigational Site

    St Louis, Missouri, 63136

  • Pfizer Investigational Site

    Terre Haute, Indiana, 47802

  • Pfizer Investigational Site

    Thornton, Colorado, 80260-

  • Pfizer Investigational Site

    Troy, New York, 12180

  • Pfizer Investigational Site

    Tualatin, Oregon, 97062

  • Pfizer Investigational Site

    Tucson, Arizona, 85710

  • Pfizer Investigational Site

    Tucson, Arizona, 85712

  • Pfizer Investigational Site

    Tucson, Arizona, 85745

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136

  • Pfizer Investigational Site

    Tuscon, Arizona, 85704

  • Pfizer Investigational Site

    Tyler, Texas, 75702

  • Pfizer Investigational Site

    Vancouver, Washington, 98684-6930

  • Pfizer Investigational Site

    Vancouver, Washington, 98684

  • Pfizer Investigational Site

    Vancouver, Washington, 98686

  • Pfizer Investigational Site

    Waco, Texas, 76712

  • Pfizer Investigational Site

    Webster, Texas, 77598

  • Pfizer Investigational Site

    Weslaco, Texas, 78596

  • Pfizer Investigational Site

    Westminster, Maryland, 21157

  • Pfizer Investigational Site

    Wichita Falls, Texas, 76310

  • Pfizer Investigational Site

    Williamsburg, Virginia, 23188

  • Pfizer Investigational Site

    Winfield, Illinois, 60190

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103

  • Pfizer Investigational Site

    Woodbridge, Virginia, 22191

  • Pfizer Investigational Site

    Woodbury, Minnesota, 55125

  • Pfizer Investigational Site

    Wytheville, Virginia, 24382

Other trials in United States

About this study

Official title: Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

Being tested
exemestane (Aromasin), tamoxifen + exemestane
Medical subject headings
Breast Neoplasms

What participants receive

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

  • exemestane (Aromasin)Drug

    Also called aromasin

    exemestane, orally, 25 mg, for 5 years

  • tamoxifen + exemestaneDrug

    tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Study groups in NCT00036270
Study groupRoleWhat they receive
exemestaneExperimentalNot described
Receives: Drug: exemestane (Aromasin)
tamoxifen + exemestaneExperimentalNot described
Receives: Drug: tamoxifen + exemestane

What is being measured

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

  1. Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

    Measured: Baseline (Month 0) up to 2.75 years

  2. Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years

    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

    Measured: Baseline (Month 0) up to 5 years

Secondary outcomes (4)

  1. Number of Events for Overall Survival (OS)

    Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

    Measured: Baseline (Month 0) up to 5 years

  2. Time to New Primary Breast Cancers

    New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).

    Measured: Baseline (Month 0) up to 5 years

  3. Number of Events for Time to Relapse

    Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.

    Measured: Baseline (Month 0) up to 5 years

  4. Number of Participants With New Primary Non-breast Cancers

    Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.

    Measured: Baseline (Month 0) up to 5 years

Timeline

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

  1. First posted9 May 2002 (estimated)
  2. Study startAug 2001
  3. Primary completionOct 2008
  4. Study completionFeb 2011

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
9,779 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036270
Sponsor's protocol ID
971-ONC-0028-081
Other IDs
A5991026
Acronym
TEAM
Status last verified
Oct 2015
First submitted
8 May 2002
Last updated
28 Oct 2015
Data monitoring committee
Yes

Publications

  • Leblanc A, Beltran-Bless AA, Pond GR, El Emam K, Juwara L, Clemons L, Bayani J, Pilgram L, Pharoah P, Mallon E, Taylor KJ, Markopoulos C, Dirix L, Vandermeer L, Hilton J, Savard MF, Bartlett JMS, Clemons M. Prognostic and predictive performance of PREDICT 2.1, PREDICT v3, and RSClin in node-negative early breast cancer: a TEAM pathology substudy. Breast Cancer Res Treat. 2026 Feb 5;215(3):74. doi: 10.1007/s10549-026-07909-5.

    PubMed 41642493

  • Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.

    PubMed 35100692

  • Noordhoek I, Blok EJ, Meershoek-Klein Kranenbarg E, Putter H, Duijm-de Carpentier M, Rutgers EJT, Seynaeve C, Bartlett JMS, Vannetzel JM, Rea DW, Hasenburg A, Paridaens R, Markopoulos CJ, Hozumi Y, Portielje JEA, Kroep JR, van de Velde CJH, Liefers GJ. Overestimation of Late Distant Recurrences in High-Risk Patients With ER-Positive Breast Cancer: Validity and Accuracy of the CTS5 Risk Score in the TEAM and IDEAL Trials. J Clin Oncol. 2020 Oct 1;38(28):3273-3281. doi: 10.1200/JCO.19.02427. Epub 2020 Jul 24.

    PubMed 32706636

  • Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.

    PubMed 29885375

  • Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.

    PubMed 24091623

  • van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.

    PubMed 21247627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane (Aromasin) and tamoxifen + exemestane in people with Breast Neoplasms, run by Pfizer at 179 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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?

Yes. Results are posted in the registry (first posted 4 Dec 2009). 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?

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years (time frame: Baseline (Month 0) up to 2.75 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 NCT00036270, which also lists 6 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 28 Oct 2015.

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