Breast CancerPhase 3FACENCT00248170
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
A Phase 3 study testing Letrozole and Anastrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 259 sites in 20 countries.
Trial summary
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Read more about this study
- Who is it for?
- Ages 33 to 96 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,172 participants
- Where
- 259 sitesin 20 countries
- Study dates
- Dec 2005to Sep 2014
- 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 33 to 96 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
Who cannot join
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
259 sites in 20 countries.
259 sites in 20 countries
United States42 sites
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Texas Oncology, P.A.
Bedford, Texas, 76022
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, 35205
Aultman Cancer Center
Canton, Ohio, 44710
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27511
Chattanooga Oncology and Hematology Assoicates, PC
Chattanooga, Tennessee, 37404
Sarah Cannon Oncology Hematology Care, Inc
Cincinnati, Ohio, 45242
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230
Texas Cancer Center ( Medical City Dallas Hospital)
Dallas, Texas, 75230
Texas Oncology Presbyterian Hospital
Dallas, Texas, 75246
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology Texas Oncology PA
Dallas, Texas, 75251
Texas Cancer Center Denton
Denton, Texas, 76210
El Paso Cancer Treatment Ctr-East
El Paso, Texas, 79915
Oncology Associates of Oregon, PC
Eugene, Oregon, 97401-8122
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Northern Arizona Hematology/Oncology Associates, P.C.
Flagstaff, Arizona, 86001
Florida Cancer Specialists
Fort Meyers, Florida, 33901
Texas Oncology, P.A.
Fort Worth, Texas, 76104
San Antonio Tumor and Blood Clinic
Fredericksburg, Texas, 78624
MD Anderson Cancer Center/University of Texas
Houston, Texas, 77030
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227
Sarah Cannon Research Institute
Jacksonville, Florida, 32256
Medical Oncology Associates of Wyorning Valley, PC
Kingston, Pennsylvania, 18704
Longview Cancer Center
Longview, Texas, 75601
South Texas Cancer Center- McAllen
McAllen, Texas, 78503
Allison Cancer Center
Midland, Texas, 79701-5946
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Oncology & Hematology Associates, PC
New London, Connecticut, 06320
Cancer Centers of Florida PA
Ocoee, Florida, 34761
Florida Cancer Institute
Orlando, Florida, 32804
Kansas City Cancer Center
Overland Park, Kansas, 66210
Texas Cancer Center- Sherman
Sherman, Texas, 75090-0504
St. Louis Cancer & Breast Institute
St Louis, Missouri, 63141
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705
New York Oncology Hematology, P.C. NYOH Latham
Troy, New York, 12180
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists, P.C.
Vancover, Washington, 98664
Waco Cancer and Research Center
Waco, Texas, 76712
Wichita Community Clinical Oncology Program
Wichita, Kansas, 67214
Germany35 sites
Novartis Investigative Site
Amberg, 92224
Novartis Investigative Site
Bayreuth, 95445
Novartis Investigative Site
Berlin, 10317
Novartis Investigative Site
Berlin, 10365
Novartis Investigative Site
Berlin, 10713
Novartis Investigative Site
Berlin, 10967
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bremen, 28205
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 65929
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Freiburg im Breisgau, 79110
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hanover, 30559
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Lüneburg, 21339
Novartis Investigative Site
Magdeburg, 39108
Novartis Investigative Site
München, 80336
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Offenbach, 63069
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Trier, 54290
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89070
Novartis Investigative Site
Wiesbaden, 65189
Novartis Investigative Site
Wiesbaden, D-65199
Novartis Investigative Site
Witten, 58452
Australia24 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Auckland
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Dunedin
Novartis Investigative Site
East Bentleigh, Victoria, 3165
Novartis Investigative Site
Epping, Victoria, 3076
Novartis Investigative Site
Footscray, Victoria, 3011
Novartis Investigative Site
Franston, Victoria, 3199
Novartis Investigative Site
Garran, Australian Capital Territory, 2605
Novartis Investigative Site
Hamilton, 3240
Novartis Investigative Site
Malvern, Victoria, 3144
Novartis Investigative Site
Nambour, Queensland, 4560
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
Perth, Western Australia, 6000
Novartis Investigative Site
Perth, Western Australia, 6005
Novartis Investigative Site
Port Macquarie, New South Wales, 2444
Novartis Investigative Site
Randwick, New South Wales, 2031
Novartis Investigative Site
Redcliff, Queensland, 4020
Novartis Investigative Site
Sydney, New South Wales, 2060
Novartis Investigative Site
Toorak Gardens, South Australia, 5065
Novartis Investigative Site
Tweed Heads, New South Wales, 2485
Novartis Investigative Site
Waratah, New South Wales, 2298
Novartis Investigative Site
Wodonga, Victoria, 3690
Italy20 sites
Novartis Investigative Site
Antella - Bagno A Ripoli, FI, 50011
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bari, BA, 70126
Novartis Investigative Site
Biella, BI, 13051
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Castelfranco Veneto, TV, 31033
Novartis Investigative Site
Catania, CT, 95124
Novartis Investigative Site
Chieti, CH, 66100
Novartis Investigative Site
Fermo, 63122
Novartis Investigative Site
Forlì, FO, 47100
Novartis Investigative Site
Milan, MI, 20121
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Modena, MO, 41100
Novartis Investigative Site
Montevarchi, AR, 52025
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Roma, RM, 00135
Novartis Investigative Site
Roma, RM, 00167
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Udine, UD, 33100
Novartis Investigative Site
Verona, VR, 37126
Japan20 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8677
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Chuo-ku, Tokyo, 104-8560
Novartis Investigative Site
Fukuoka, Fukuoka, 811-1395
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Novartis Investigative Site
Kawasaki, Kanagawa, 216-8511
Novartis Investigative Site
Kitaadachi-gun, Saitama, 362-0806
Novartis Investigative Site
Kitakyushu, Fukuoka, 802-0077
Novartis Investigative Site
Koto, Tokyo, 135-8550
Novartis Investigative Site
Kyoto, Kyoto, 606-8507
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Matsuyama, Ehime, 791-0280
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Novartis Investigative Site
Osaka, Osaka, 537-8511
Novartis Investigative Site
Sapporo, Hokkaido, 003-0804
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Shizuoka, Shizuoka, 420-8527
Novartis Investigative Site
Suita, Osaka, 565-0871
Novartis Investigative Site
Yokohama, Kanagawa, 241-8515
United Kingdom18 sites
Novartis Investigative Site
Belfast, BT9 7AB
Novartis Investigative Site
Bournemouth, BH7 7DW
Novartis Investigative Site
Bristol, BS16 1JE
Novartis Investigative Site
Chelmsford, CM1 7ET
Novartis Investigative Site
Colchester, CO3 3NB
Novartis Investigative Site
Glasgow, Glasgow, G11 6NT
Novartis Investigative Site
Hull, East Yorkshire, HU8 9HE
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, N18 1QX
Novartis Investigative Site
London, NW3 2QG
Novartis Investigative Site
Manchester, M23 9LT
Novartis Investigative Site
Merseyside, L63 4JY
Novartis Investigative Site
Northwood, Middlesex, HA6 2RN
Novartis Investigative Site
Plymouth, PL6 8DH
Novartis Investigative Site
Rhyl, LL18 5UJ
Novartis Investigative Site
Sheffiled, S10 2SJ
Novartis Investigative Site
Shrewsbury, SY38XQ
Novartis Investigative Site
Surrey, SM2 5PT
Austria16 sites
Novartis Investigative Site
Feldkirch, A-6807
Novartis Investigative Site
Friesach, 9360
Novartis Investigative Site
Graz, Austria, A-8036
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Guessing, 7540
Novartis Investigative Site
Innsbruck, 6020
Novartis Investigative Site
Leoben, A-8700
Novartis Investigative Site
Linz, 4010
Novartis Investigative Site
Linz, A-4020
Novartis Investigative Site
Salzburg, 5020
Novartis Investigative Site
Vienna, Austria, 1090
Novartis Investigative Site
Vienna, A-1090
Novartis Investigative Site
Vienna, A-1140
Novartis Investigative Site
Villach, 9500
Novartis Investigative Site
Wels, Austria, A-4600
Novartis Investigative Site
Wiener Neustadt, 2700
France14 sites
Novartis Investigative Site
Angers, 49033
Novartis Investigative Site
Caen, 14021
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Le Chesnay, 78157
Novartis Investigative Site
Lyon, F-69373
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Montbéliard, 25209
Novartis Investigative Site
Montpellier, F-34094
Novartis Investigative Site
Nice, 06050
Novartis Investigative Site
Périgueux Cédex, 24004
Novartis Investigative Site
Perpignan, 66000
Novartis Investigative Site
Rennes, 35062
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Toulouse, 31078
Belgium12 sites
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Antwerp, 2020
Novartis Investigative Site
Bonheiden, 2820
Novartis Investigative Site
Brasschaat, 2930
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Libramont, 6800
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Turnhout, 2300
Novartis Investigative Site
Verviers, 4800
Novartis Investigative Site
Wilrijk, 2610
Denmark10 sites
Novartis Investigative Site
Aalborg, Denmark, DK-9000
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Herlev, DK-2730
Novartis Investigative Site
Herning, DK-7400
Novartis Investigative Site
Hillerød, DK-3400
Novartis Investigative Site
Næstved, DK-4700
Novartis Investigative Site
Odense C, DK-5000
Novartis Investigative Site
Roskilde, DK-4000
Novartis Investigative Site
Vejle, DK-7100
Novartis Investigative Site
Viborg, DK-8800
Spain10 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
A Coruña, Galicia, 15009
Novartis Investigative Site
Alicante, Alicante, 03010
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Valencia, Valencia, 46009
Novartis Investigative Site
Zaragoza, Zaragoza, 50009
Canada8 sites
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P7
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1S 4L8
Novartis Investigative Site
Regina, Saskatchewan, S4T 7T1
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 4H4
Novartis Investigative Site
Toronto, Ontario, M4C 3E7
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Ireland6 sites
Novartis Investigative Site
Cork
Novartis Investigative Site
Dublin, DUBLIN 9
Novartis Investigative Site
Dublin
Novartis Investigative Site
Galway, Ireland
Novartis Investigative Site
Letterkenny
Novartis Investigative Site
Limerick
Netherlands5 sites
Novartis Investigative Site
Eindhoven, 5623 EJ
Novartis Investigative Site
Enschede, 7511 JH
Novartis Investigative Site
Nijmegen, 6532 SZ
Novartis Investigative Site
Rotterdam, 3083 AN
Novartis Investigative Site
Veldhoven, 5504 DB
China4 sites
Novartis Investigative Site
Beijing, 100021
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300060
Israel4 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Rehovot, 76100
Novartis Investigative Site
Tel Aviv, 6423906
Novartis Investigative Site
Tel HaShomer, 52621
Switzerland4 sites
Novartis Investigative Site
Chur, 7000
Novartis Investigative Site
Lucerne, 6000
Novartis Investigative Site
Schaffhausen, 8208
Novartis Investigative Site
Winterthur, 8401
South Korea3 sites
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 410-769
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, 01812
Sweden3 sites
Novartis Investigative Site
Lund, 221 85
Novartis Investigative Site
Stockholm, SE-118 83
Novartis Investigative Site
Uppsala, SE-751 85
About this study
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Anastrozole
- Keywords
- Breast cancer, letrozole, anastrozole, adjuvant, postmenopausal, FACE
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
2.5 mg tablets
AnastrozoleDrug
1 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | 2.5 mg by mouth (p.o.) once daily Receives: Drug: Letrozole |
| Anastrozole | Active comparator | 1 mg p.o. once daily Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
Measured: 84 months
Secondary outcomes (7)
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Measured: 84 months
Time to Development of Distant Metastases
Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
Measured: 84 months
Time to Development of Contra Lateral Breast Cancer
Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
Measured: 84 months
Distant Disease-free Survival
Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
Measured: 84 months
Change From Baseline in Serum Lipid Profiles
Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Measured: baseline, 6, 12, 24, 36, 48 and 60 months
Percentage of Participants Who Experienced Clinical Fracture Events
The incidence of clinical fractures was analyzed.
Measured: 84 months
Percentage of Participants Who Experienced Cardiovascular Events
The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Measured: 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248170
- Sponsor's protocol ID
- CFEM345D2411
- Other IDs
- 2005-004263-35, EUDRACT number 2005-004263-35, 2005
- Acronym
- FACE
- Status last verified
- Mar 2016
- First submitted
- 2 Nov 2005
- Last updated
- 19 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00248170
- Acronym / sponsor ID
- FACE / CFEM345D2411
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, letrozole, anastrozole, adjuvant, postmenopausal, FACE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,172 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole2.5 mg by mouth (p.o.) once daily |
| Anastrozole | Active comparator | Drug: Anastrozole1 mg p.o. once daily |
Who may qualify
- Ages
- 33 to 96 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
Key exclusion criteria (4 listed)
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole2.5 mg tablets | Drug | Letrozole |
| Anastrozole1 mg tablets | Drug | Anastrozole |
Primary outcome
Disease Free Survival
Time frame: 84 months
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
7 secondary outcomes
Overall Survival
Time frame: 84 months
Time to Development of Distant Metastases
Time frame: 84 months
Time to Development of Contra Lateral Breast Cancer
Time frame: 84 months
Distant Disease-free Survival
Time frame: 84 months
Change From Baseline in Serum Lipid Profiles
Time frame: baseline, 6, 12, 24, 36, 48 and 60 months
Percentage of Participants Who Experienced Clinical Fracture Events
Time frame: 84 months
Percentage of Participants Who Experienced Cardiovascular Events
Time frame: 84 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
259 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole and Anastrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 259 sites in 20 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 5 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 259 sites in United States, Germany, Australia, Italy, Japan and 15 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 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 9 Oct 2015). 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 (time frame: 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2016.