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Breast CancerPhase 3NCT00016432

Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

A Phase 3 study testing exemestane in people with Breast Cancer, run by NSABP Foundation Inc at 162 sites in 3 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

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
exemestane
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,598 participants
Where
162 sitesin 3 countries
Study dates
May 2001to Feb 2011
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis
  • Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA)
  • No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis
  • Prior surgical resection, including 1 of the following:
  • Total mastectomy and axillary dissection (modified radical mastectomy) OR
  • Lumpectomy and axillary dissection
  • Prior post-lumpectomy breast radiotherapy required
  • Prior sentinel node biopsy allowed with the exception of the following:
  • If any sentinel node is histologically positive by hematoxylin and eosin (H \& E) OR histologically suspicious on H \& E and confirmed positive by immunohistochemistry then the patient must have a complete axillary dissection
  • Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ
  • Currently disease free
  • Previously treated with tamoxifen for 57-66 months
  • Completed tamoxifen within the past 180 days
  • No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative
  • No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer)
  • No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall [complete fixation], peau d'orange, or skin edema of any magnitude)
  • Tethering or dimpling of the skin or nipple inversion allowed
  • Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease
  • Hormone receptor status:
  • Primary tumor estrogen receptor (ER) positive AND/OR
  • Progesterone receptor positive
  • Borderline ER positive tumors allowed if previously treated with tamoxifen

PATIENT CHARACTERISTICS:

Age:

  • Postmenopausal

Sex:

  • Female

Menopausal status:

  • Postmenopausal, defined as 1 of the following:
  • Prior bilateral oophorectomy
  • Absence of spontaneous menstrual cycle for more than 1 year
  • Follicle-stimulating hormone within the postmenopausal range if under 55 and had a prior hysterectomy without a bilateral oophorectomy

Performance status:

  • Not specified

Life expectancy:

  • At least 10 years

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin normal

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN
  • No systemic hepatic disease that would preclude study participation

Renal:

  • Creatinine no greater than 1.5 times ULN
  • No systemic renal disease that would preclude study participation

Cardiovascular:

  • No systemic cardiovascular disease that would preclude study participation

Other:

  • No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
  • No nonmalignant systemic disease that would preclude study participation
  • No psychiatric or addictive disorder that would preclude informed consent
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior adjuvant chemotherapy allowed if administered concurrently with or prior to tamoxifen

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA)
  • Estring or estrogen vaginal cream at 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week allowed
  • No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene)

Radiotherapy:

  • See Disease Characteristics
  • Prior post-mastectomy loco-regional radiotherapy or post-lumpectomy regional radiotherapy allowed

Surgery:

  • See Disease Characteristics

Other:

  • Prior participation in other adjuvant NSABP study allowed if study was reported in peer-review publication or tamoxifen was not a study drug
  • Concurrent bisphosphonates or calcitonin for prevention or treatment of osteoporosis allowed
  • Concurrent statins (simvastatin, pravastatin, fluvastatin, atorvastatin, or lovastatin) or other drugs to control lipid levels allowed

Trial locations and contacts

162 sites in 3 countries.

162 sites in 3 countries

United States150 sites

  • Akron City Hospital

    Akron, Ohio, 44309

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Illinois Oncology, Ltd.

    Belleville, Illinois, 62221

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • National Naval Medical Center

    Bethesda, Maryland, 20889-5000

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center

    Burlington, North Carolina, 27216

  • Vermont Cancer Center

    Burlington, Vermont, 05405-0075

  • Aultman Cancer Center

    Canton, Ohio, 44710

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Camcare Health

    Charleston, West Virginia, 25304

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Jewish Hospital of Cincinnati, Inc.

    Cincinnati, Ohio, 45236

  • Barrett Cancer Center

    Cincinnati, Ohio, 45267-0502

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Center for Oncology Research and Treatment, Medical City Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Halifax Medical Center

    Daytona Beach, Florida, 32114

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Michigan State University

    East Lansing, Michigan, 48824

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • University of Connecticut

    Farmington, Connecticut, 06032

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • California Cancer Center

    Fresno, California, 93720

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Cancer Center of Hawaii

    Honolulu, Hawaii, 96826

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Clarian Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Scripps Cancer Center

    La Jolla, California, 92037

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 43213

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Institute

    Loma Linda, California, 92354

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Norton Healthcare System

    Louisville, Kentucky, 40202-5070

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55415

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Louisiana State University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19899

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Virginia Oncology Associates - Newport News

    Newport News, Virginia, 23606

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • West Suburban Hospital Medical Center

    Oak Park, Illinois, 60302

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Hospital Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Comprehensive Cancer Centers of the Desert

    Palm Springs, California, 92262

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • Cancer Research Network Inc.

    Plantation, Florida, 33324

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97213

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sutter Cancer Center

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Oncology Hematology Consultants

    Sarasota, Florida, 34239

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Lincoln Medical and Mental Health Center

    The Bronx, New York, 10451

  • MBCCOP-Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • South Pointe Hospital - Cancer Care Center

    Warrensville Heights, Ohio, 44122

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • York Cancer Center

    York, Pennsylvania, 17315

Other trials in United States

Canada11 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico1 site

  • MBCCOP - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

About this study

Official title: A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.

Read the detailed description

OBJECTIVES:

  • Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer.
  • Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients.
  • Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients.
  • Evaluate the quality of life of a subset of these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral exemestane daily for 5 years.
  • Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years.

Quality of life is assessed at baseline and then every 6 months for 5.5 years.

Patients are followed every 6 months for 6 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.

Conditions
Breast Cancer
Being tested
exemestane, Placebo
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • exemestaneDrug

    25 mg for 5 years

  • PlaceboDrug

    Placebo

Study groups in NCT00016432
Study groupRoleWhat they receive
Group 1ExperimentalExemestane
Receives: Drug: exemestane
Group 2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Disease-free survival

    Measured: Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.

Secondary outcomes (3)

  1. Overall survival

    Measured: Death from any cause

  2. Time to treatment failure

    Measured: time from randomization to recurrence or contralateral second primary cancer

  3. Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement

    Measured: measurements taken at regular intervals from randomization through 6 years following randomiztion

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2001
  3. Primary completionOct 2003
  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
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,598 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016432
Sponsor's protocol ID
NSABP B-33
Other IDs
CDR0000068640
Status last verified
Apr 2011
First submitted
6 May 2001
Last updated
19 Apr 2011
Results posted
No

Publications

  • Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. doi: 10.1200/JCO.2007.14.0228. Epub 2008 Mar 10.

    PubMed 18332472

  • Mamounas E, Jeong J-H, Wickerham L, et al.: Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-49, S22, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane in people with Breast Cancer, run by NSABP Foundation Inc at 162 sites in 3 countries.

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

Who may be eligible to take part?

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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Canada, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?

Disease-free survival (time frame: Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.). 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 NCT00016432, 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 19 Apr 2011.

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