Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer (SOLE)

August 10, 2026 updated by: ETOP IBCSG Partners Foundation

SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period.

Secondary

  • Compare overall survival of patients treated with these two regimens.
  • Compare distant DFS of these patients.
  • Compare breast cancer-free interval of these patients.
  • Compare sites of first DFS failure in these patients.
  • Compare second (nonbreast) malignancies in these patients.
  • Compare deaths without prior cancer events in these patients.
  • Compare adverse events resulting from these two regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and type of prior endocrine therapy (selective estrogen receptor modulators [SERMs] alone vs aromatase inhibitors [AIs] alone vs both SERMs and AIs each for at least 1 month). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral letrozole daily for 5 years.
  • Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through 4, followed by 12 months in year 5.

After completion of study therapy, patients are followed annually.

Study Type

Interventional

Enrollment (Actual)

4884

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Armidale, New South Wales, Australia, 2350
        • Armidale Hospital
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown - Lidcombe Hospital
      • Bowral, New South Wales, Australia, 2576
        • Southern Highlands Cancer Center
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Gateshead, New South Wales, Australia, 2290
        • Breast Center
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Mcquarie Base Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Private Hospital
      • Tamworth, New South Wales, Australia, 2340
        • Tamworth Base Hospital
      • Tweed Heads, New South Wales, Australia, 2485
        • Tweed Heads Hospital
      • Waratah, New South Wales, Australia, 2310
        • Calvary Mater Newcastle
    • Tasmania
      • Burnie, Tasmania, Australia, 7320
        • North West Regional Hospital
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3135
        • Maroondah Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Feldkirch, Austria, A-6807
        • Landeskrankenhaus Feldkirch
      • Graz, Austria, A-8036
        • Medizinische Universitaet Graz
      • Innsbruck, Austria, A-6020
        • Innsbruck Universitaetsklinik
      • Linz, Austria, A-4010
        • Krankenhaus BHS Linz
      • Linz, Austria, A-4021
        • Allgemeines Krankenhaus Linz
      • Salzburg, Austria, A-5020
        • St. Johanns-Spital
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, A-1140
        • Hanusch-Krankenhaus
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
      • Vienna, Austria, A-1130
        • Krankenhaus Lainz
      • Villach, Austria, 9500
        • LKH Villach
      • Wels, Austria, 4600
        • Klinikum Kreuzschwestern Wels GmbH
  • Belgium
      • Antwerp, Belgium, B-2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Arlon, Belgium, 6700
        • Cliniques du Sud Luxembourg
      • Bonheiden, Belgium, 2820
        • Imelda vzw, Ziekenhuis
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Brussels, Belgium, B 1020
        • Centre Hospitalier Universitaire Brugmann
      • Duffel, Belgium, 2570
        • Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Haine-Saint-Paul, Belgium, 7100
        • Hopital De Jolimont
      • Hasselt, Belgium, 3500
        • Virga Jesse Hospital
      • Huy, Belgium, 4500
        • Centre Hospitalier Hutois
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Oncologisch Centrum
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Libramont, Belgium, 6800
        • Centre Hospitalier de l'Ardenne
      • Liège, Belgium, 4000
        • Centre Hospitalier Regional de la Citadelle
      • Liège, Belgium, B-4000
        • CHU Liege - Domaine Universitaire du Sart Tilman
      • Liège, Belgium, B 4000
        • Clinique Saint-Joseph
      • Merksem, Belgium, B-2170
        • Jan Palfijn Hospital
      • Ostend, Belgium, 8400
        • AZ Damiaan
      • Ottignies, Belgium, B-1340
        • Clinique Saint-PIerre
      • Rocourt, Belgium, 4000
        • Clinique Saint Vincent
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas - Sint-Niklaas
      • Turnhout, Belgium, 2300
        • Sint-Elisabethziekenhuis
      • Verviers, Belgium, B-4800
        • Centre Hospitalier Peltzer-La Tourelle
  • Chile
      • Peñalolén, Chile, 2005
        • Hospital Santiago Oriente Dr. Luis Tisne Brousse
      • Santiago, Chile
        • Instituto Nacional del Cancer
      • Santiago, Chile
        • Hospital Clinico San Borja Arriarán
      • Santiago, Chile, 29
        • Fundacion Arturo Lopez Perez
      • Santiago, Chile
        • IRAM - Chile
      • Valdivia, Chile
        • Hospital Clinico Regional de Valdivia at University Austral de Chile
      • Valparaíso, Chile
        • Hospital Carlos Van Buren
  • Denmark
      • Aarhus C, Denmark, DK-8000
        • Aarhus Universitetshospital - Aarhus Sygehus
      • Copenhagen, Denmark, DK-2730
        • Copenhagen County Herlev University Hospital
      • Esbjerg, Denmark, DK-6700
        • Centralsygehus Esbjerg
      • Herning, Denmark, DK-7400
        • Herning Central Hospital
      • Hillerød, Denmark, 3400
        • Hillerod Hospital
      • Næstved, Denmark, 4700
        • Naestved Hospital
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Roskilde Amtssygehuset
      • Rønne, Denmark, 3700
        • Bornholms Hospital
      • Sønderborg, Denmark, 6400
        • Sonderborg Sygehus
      • Vejle, Denmark, DK-7100
        • Vejle Sygehus
      • Viborg, Denmark, 8800
        • Viborg Sygehus
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
  • Germany
      • Aalen, Germany, 73430
        • Aalen Breast Center
      • Bielefeld, Germany, D-33602
        • Onkologische Schwerpunktpraxis Bielefeld
      • Celle, Germany, 29223
        • Allgemeinen Krankenhaus Celle Kinderklinik
      • Deggendorf, Germany, 94469
        • Klinikum Deggendorf
      • Fürth, Germany, 90766
        • Praxis Dr. Wilke - Onkologie am Klinikum Fuerth
      • Hanover, Germany, 30559
        • Vinzenzkrankenhaus Hannover gGmbH
      • Hanover, Germany, D-30171
        • Henriettenstiftung Krankenhaus
      • Hanover, Germany, D-30177
        • Gynaekologisch-onkologische Praxis Hannover
      • Ilsede, Germany, 31241
        • Frauenheilkunde u. Geburtshilfe
      • Lich, Germany, D-35423
        • Asklepios Klinik Lich
      • Mannheim, Germany, D68161
        • Gemeinschaftspraxis Gynaekologie & Geburtshilfe
      • Meiningen, Germany, 98617
        • Klinikum Meiningen GmbH
      • Memmingen, Germany, 87700
        • Klinikum Memmingen
      • Offenbach, Germany, D-63069
        • Klinikum Offenback GmbH
      • Schwäbisch Hall, Germany, D-74523
        • Deaconess Hospital
      • Stendal, Germany, 39576
        • Johanniter Kankenhaus Stendal
      • Suhl, Germany, 98527
        • SRH Zentralklinikum Suhl GmbH
      • Tübingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology - Budapest
      • Szeged, Hungary, H-6720
        • Szeged University
  • India
      • Mumbai, India, 400012
        • Tata Memorial Hospital
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Biella, Italy, 13900
        • Ospedale degli Infermi - ASL 12
      • Bolzano, Italy, 39100
        • Azienda Sanitaria di Bolzano
      • Brescia, Italy, 25123
        • Spedali Civili di Brescia
      • Brindisi, Italy, 72100
        • A. Perrino Hospital
      • Cremona, Italy, 26100
        • Azienda Istituti Ospitalieri
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italy, 20141
        • European Institute of Oncology
      • Pavia, Italy, I-27100
        • Fondazione Salvatore Maugeri
      • Prato, Italy, 59100
        • Misericordia e Dolce Hospital
      • Rimini, Italy, 47900
        • Ospedale Civile Rimini
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Japan
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan
        • Sagara Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Kumamoto University Faculty of Medical and Pharmaceutical Sciences
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Osaka, Osaka, Japan, 581-0069
        • Yao Municipal Hospital
      • Sakai, Osaka, Japan, 1179-3
        • Osaka Rosai Hospital
    • Tokyo
      • Tokyo, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan - Komagome Hospital
  • New Zealand
      • Christchurch, New Zealand, 1
        • Christchurch Hospital
      • Hamilton, New Zealand, 2020
        • Waikato Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Russia
      • Moscow, Russia, 115478
        • Russian Academy of Medical Sciences Cancer Research Center
  • South Africa
      • Cape Town, South Africa, 7505
        • Tygerberg Hospital
      • Sandton, South Africa, 2199
        • Sandton Oncology Medical Research
  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebrón University Hospital
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Hospital Ramón Y Cajal
      • Madrid, Spain, 28033
        • M. D. Anderson International Espana SA
      • Palma de Mallorca, Spain, 07198
        • Hospital Son Llatzer
      • Reus, Spain, 43201
        • Hospital Sant Joan de Reus
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Torrevieja, Spain, 03180
        • Hospital de Torrevieja
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
  • Sweden
      • Borås, Sweden, 501 15
        • Lasarettet i Boras
      • Eskilstuna, Sweden
        • Malarsjukhuset Hospital
      • Gothenburg, Sweden, S-413 45
        • Sahlgrenska University Hospital
      • Lidköping, Sweden, S-53185
        • Lidköping Hospital
      • Skövde, Sweden, 541 85
        • Skaraborgs Hospital
      • Stockholm, Sweden, S-141 86
        • Karolinska University Hospital - Huddinge
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Kantonsspital Aarau
      • Baden, Switzerland, CH-5404
        • Kantonsspital Baden
      • Bellinzona, Switzerland, CH-6500
        • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Bern, Switzerland, CH-3012
        • Oncocare Sonnenhof-Klinik Engeriedspital
      • Cham, Switzerland, CH-6330
        • AndreasKlinik Cham Zug
      • Chur, Switzerland, CH-7000
        • Kantonsspital Graubuenden
      • Frauenfeld, Switzerland, 8501
        • Brustzentrum Thurgau at Kantonsspital Frauenfeld
      • Fribourg, Switzerland, 1708
        • Kantonsspital Freiburg
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Locarno, Switzerland, 6600
        • Ospedale "la Carita", Locarno
      • Locarno, Switzerland, 6600
        • Lago Maggiore Oncology Foundation
      • Lugano, Switzerland, CH-6903
        • Ospedale Civico
      • Mendrisio, Switzerland, CH-6850
        • Ospedale Beata Vergine
      • Olten, Switzerland, CH-4600
        • Kantonsspital Olten
      • Sankt Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Sankt Gallen, Switzerland, CH-9006
        • Tumor Zentrum ZeTup St. Gallen und Chur
      • Sion, Switzerland, CH -1951
        • Hopital Regional de Sion-Herens-Conthey
      • Thun, Switzerland, 3600
        • Regionalspital
      • Winterthur, Switzerland, CH-8400
        • Kantonsspital Winterthur
      • Zurich, Switzerland, CH-8008
        • Breast Center
      • Zurich, Switzerland, CH-8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8091
        • Universitaetsspital Zuerich
  • United Kingdom
    • England
      • Melrose, England, United Kingdom, TD6 9BS
        • Borders General Hospital
    • Scotland
      • Dumfries, Scotland, United Kingdom, DG1 4AP
        • Dumfries & Galloway Royal Infirmary
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02130-3400
        • Faulkner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:

    • Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
    • Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease
    • Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
    • Clinically disease-free

  • Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both

    • When calculating 4-6 years, neoadjuvant endocrine therapy should not be included
  • No evidence of recurrent disease or distant metastatic disease
  • No prior bilateral breast cancer

PATIENT CHARACTERISTICS:

  • Female

  • Must be postmenopausal by any of the following criteria:

    • Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)
    • Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)

    • Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)

      • Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above
  • Clinically adequate hepatic function
  • No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy
  • No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma
  • No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
  • No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 12 months since prior and no other concurrent endocrine SERM/AI therapy

  • Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:

    • Neoadjuvant chemotherapy
    • Neoadjuvant endocrine therapy
    • Adjuvant chemotherapy
    • Trastuzumab (Herceptin®)
    • Ovarian ablation
    • Gonadotropin releasing hormone analogues
    • Lapatinib ditosylate
  • No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous letrozole
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
Experimental: Intermittent letrozole
Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS)
Time Frame: 5-year estimates, reported at a median follow-up of 60 months
Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.
5-year estimates, reported at a median follow-up of 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5-year estimates, reported at a median follow-up of 60 months
Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).
5-year estimates, reported at a median follow-up of 60 months
Distant Recurrence-free Interval (DRFI)
Time Frame: 5-year estimates, reported at a median follow-up of 60 months

Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.*

*This endpoint replaced DDFS, which was specified in the protocol
5-year estimates, reported at a median follow-up of 60 months
Breast Cancer-free Interval
Time Frame: 5-year estimates, reported at a median follow-up of 60 months
Duration of time from randomization to the first indication of the following events: invasive breast recurrence at local, regional or distant sites; a new invasive cancer in the contralateral breast (second non-breast malignancies are ignored). In the absence of an event, BCFI was censored at the date of last follow-up visit or date of death without prior breast cancer event.
5-year estimates, reported at a median follow-up of 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Collaborators

Breast International Group

Investigators

  • Study Chair: Marco Colleoni, MD, European Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimated)

November 5, 2007

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCSG 35-07 / BIG 1-07
  • 2007-001370-88 (EudraCT Number)
  • CDR0000574249 (Registry Identifier: CT.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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