Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT) (COMPACT)

November 9, 2012 updated by: AstraZeneca

Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy

Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2313

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

  • Germany
      • Aachen, Germany
        • Research Site
      • Aalen, Germany
        • Research Site
      • Ahaus, Germany
        • Research Site
      • Albstadt, Germany
        • Research Site
      • Altotting, Germany
        • Research Site
      • Alzey, Germany
        • Research Site
      • Amberg, Germany
        • Research Site
      • Apolda, Germany
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Aschersleben, Germany
        • Research Site
      • Augsburg, Germany
        • Research Site
      • Aurich, Germany
        • Research Site
      • Babenhausen, Germany
        • Research Site
      • Bad Durkheim, Germany
        • Research Site
      • Bad Herrenalb, Germany
        • Research Site
      • Bad Nauheim, Germany
        • Research Site
      • Bad Neuenahr-Ahrweiler, Germany
        • Research Site
      • Bad Oeynhausen, Germany
        • Research Site
      • Bad Oldesloe, Germany
        • Research Site
      • Bad Reichenhall, Germany
        • Research Site
      • Bad Saarow, Germany
        • Research Site
      • Bad Segeberg, Germany
        • Research Site
      • Bad Tolz, Germany
        • Research Site
      • Bad Urach, Germany
        • Research Site
      • Bad Wildbad, Germany
        • Research Site
      • Bad Wildungen, Germany
        • Research Site
      • Bad Windsheim, Germany
        • Research Site
      • Baden-Baden, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Bautzen, Germany
        • Research Site
      • Bayreuth, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Berlin-Kreuzberg, Germany
        • Research Site
      • Berlin-Steglitz, Germany
        • Research Site
      • Bexbach, Germany
        • Research Site
      • Biberach, Germany
        • Research Site
      • Biedenkopf, Germany
        • Research Site
      • Bielefeld, Germany
        • Research Site
      • Bietigheim-Bissingen, Germany
        • Research Site
      • Blankenburg, Germany
        • Research Site
      • Blumberg in Baden, Germany
        • Research Site
      • Boblingen, Germany
        • Research Site
      • Bocholt, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Borna, Germany
        • Research Site
      • Bottrop, Germany
        • Research Site
      • Brackenheim, Germany
        • Research Site
      • Bramsche, Germany
        • Research Site
      • Brandenburg, Germany
        • Research Site
      • Braunschweig, Germany
        • Research Site
      • Bretten, Germany
        • Research Site
      • Bruchsal, Germany
        • Research Site
      • Bruhl, Germany
        • Research Site
      • Buhl, Germany
        • Research Site
      • Bunde, Germany
        • Research Site
      • Burg, Germany
        • Research Site
      • Burghausen, Germany
        • Research Site
      • Celle, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Cloppenburg, Germany
        • Research Site
      • Coburg, Germany
        • Research Site
      • Coesfeld, Germany
        • Research Site
      • Dachau, Germany
        • Research Site
      • Damme, Germany
        • Research Site
      • Datteln, Germany
        • Research Site
      • Demmin, Germany
        • Research Site
      • Dessau, Germany
        • Research Site
      • Dessau-Rosslau, Germany
        • Research Site
      • Diessen, Germany
        • Research Site
      • Dillenburg, Germany
        • Research Site
      • Dillingen, Germany
        • Research Site
      • Dinkelsbuhl, Germany
        • Research Site
      • Ditzingen, Germany
        • Research Site
      • Doberlug-Kirchhain, Germany
        • Research Site
      • Dornstadt, Germany
        • Research Site
      • Dorsten, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Dreieich, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Duisburg, Germany
        • Research Site
      • Duren, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Ebermannstadt, Germany
        • Research Site
      • Ebersbach, Germany
        • Research Site
      • Eggenfelden, Germany
        • Research Site
      • Eisenach, Germany
        • Research Site
      • Ellwangen, Germany
        • Research Site
      • Elmshorn, Germany
        • Research Site
      • Emmendingen, Germany
        • Research Site
      • Erding, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Ergolding, Germany
        • Research Site
      • Erkelenz, Germany
        • Research Site
      • Eschweiler, Germany
        • Research Site
      • Esens, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Ettlingen, Germany
        • Research Site
      • Euskirchen, Germany
        • Research Site
      • Eutin, Germany
        • Research Site
      • Feuchtwangen, Germany
        • Research Site
      • Flensburg, Germany
        • Research Site
      • Frankenberg, Germany
        • Research Site
      • Frankenthal, Germany
        • Research Site
      • Frankfurt (Oder), Germany
        • Research Site
      • Frechen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Freising, Germany
        • Research Site
      • Freital, Germany
        • Research Site
      • Freyung, Germany
        • Research Site
      • Friedrichshafen, Germany
        • Research Site
      • Fulda, Germany
        • Research Site
      • Furstenfeldbruck, Germany
        • Research Site
      • Furstenwalde, Germany
        • Research Site
      • Furth, Germany
        • Research Site
      • Garbsen, Germany
        • Research Site
      • Geesthacht, Germany
        • Research Site
      • Geilenkirchen, Germany
        • Research Site
      • Gelsenkirchen, Germany
        • Research Site
      • Georgsmarienhutte, Germany
        • Research Site
      • Gera, Germany
        • Research Site
      • Geretsried, Germany
        • Research Site
      • Gerlingen, Germany
        • Research Site
      • Gersthofen, Germany
        • Research Site
      • Giesen, Germany
        • Research Site
      • Gifhorn, Germany
        • Research Site
      • Gladbeck, Germany
        • Research Site
      • Goppingen, Germany
        • Research Site
      • Goslar, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Grafelfing, Germany
        • Research Site
      • Griesheim, Germany
        • Research Site
      • Gummersbach, Germany
        • Research Site
      • Gunzburg, Germany
        • Research Site
      • Gustrow, Germany
        • Research Site
      • Haiger, Germany
        • Research Site
      • Halberstadt, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Halle / Saale, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hameln, Germany
        • Research Site
      • Hamm, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Hartha, Germany
        • Research Site
      • Heide, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Heidenheim, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Heinsberg, Germany
        • Research Site
      • Hemmingen, Germany
        • Research Site
      • Henstedt-Ulzburg, Germany
        • Research Site
      • Heppenheim, Germany
        • Research Site
      • Herborn, Germany
        • Research Site
      • Herbrechtingen, Germany
        • Research Site
      • Herdecke, Germany
        • Research Site
      • Herford, Germany
        • Research Site
      • Hermsdorf, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Herzberg, Germany
        • Research Site
      • Herzberg am Harz, Germany
        • Research Site
      • Hessisch Oldendorf, Germany
        • Research Site
      • Hilchenbach, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Hillesheim, Germany
        • Research Site
      • Hochstadt, Germany
        • Research Site
      • Hof, Germany
        • Research Site
      • Hofheim, Germany
        • Research Site
      • Holzminden, Germany
        • Research Site
      • Homburg/Saar, Germany
        • Research Site
      • Huckelhoven, Germany
        • Research Site
      • Ilsede, Germany
        • Research Site
      • Ingolstadt, Germany
        • Research Site
      • Isny, Germany
        • Research Site
      • Itzehoe, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Kahla, Germany
        • Research Site
      • Kalkar, Germany
        • Research Site
      • Karlsbad, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Kaufbeuren, Germany
        • Research Site
      • Kempten, Germany
        • Research Site
      • Kerpen, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Koblenz, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Konigs Wusterhausen, Germany
        • Research Site
      • Konstanz, Germany
        • Research Site
      • Korntal-Munchingen, Germany
        • Research Site
      • Krefeld, Germany
        • Research Site
      • Kreuztal, Germany
        • Research Site
      • Krumbach, Germany
        • Research Site
      • Kunzelsau, Germany
        • Research Site
      • Kusel, Germany
        • Research Site
      • Laatzen, Germany
        • Research Site
      • Lahnstein, Germany
        • Research Site
      • Landau, Germany
        • Research Site
      • Landshut, Germany
        • Research Site
      • Langen, Germany
        • Research Site
      • Langenhagen, Germany
        • Research Site
      • Lauf, Germany
        • Research Site
      • Lehrte, Germany
        • Research Site
      • Leichlingen, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Leisnig, Germany
        • Research Site
      • Leonberg, Germany
        • Research Site
      • Leverkusen, Germany
        • Research Site
      • Lich, Germany
        • Research Site
      • Limburg, Germany
        • Research Site
      • Lingen, Germany
        • Research Site
      • Lobau, Germany
        • Research Site
      • Lohsa OT Weisskollm, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludwigsfelde, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Luneburg, Germany
        • Research Site
      • Lunen, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Marienheide, Germany
        • Research Site
      • Markranstadt, Germany
        • Research Site
      • Marktredwitz, Germany
        • Research Site
      • Marl, Germany
        • Research Site
      • Mayen, Germany
        • Research Site
      • Meiningen, Germany
        • Research Site
      • Meissen, Germany
        • Research Site
      • Memmingen, Germany
        • Research Site
      • Mendig, Germany
        • Research Site
      • Mettingen, Germany
        • Research Site
      • Metzingen, Germany
        • Research Site
      • Minden, Germany
        • Research Site
      • Mittweida, Germany
        • Research Site
      • Moers, Germany
        • Research Site
      • Monchengladbach, Germany
        • Research Site
      • Muhldorf, Germany
        • Research Site
      • Muhlhausen, Germany
        • Research Site
      • Muhlheim, Germany
        • Research Site
      • Mulheim a. d. Ruhr, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Mutlangen, Germany
        • Research Site
      • Nauen, Germany
        • Research Site
      • Naunhof, Germany
        • Research Site
      • Neckarsulm, Germany
        • Research Site
      • Netphen, Germany
        • Research Site
      • Neubrandenburg, Germany
        • Research Site
      • Neuhaus am Rennweg, Germany
        • Research Site
      • Neumarkt, Germany
        • Research Site
      • Neumunster, Germany
        • Research Site
      • Neuruppin, Germany
        • Research Site
      • Neustadt, Germany
        • Research Site
      • Neustadt an der Weinstrasse, Germany
        • Research Site
      • Nienburg, Germany
        • Research Site
      • Nordhausen, Germany
        • Research Site
      • Nordhorn, Germany
        • Research Site
      • Numbrecht, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
      • Nurtingen, Germany
        • Research Site
      • Oberhausen, Germany
        • Research Site
      • Oberstdorf, Germany
        • Research Site
      • Ochsenfurt, Germany
        • Research Site
      • Offenbach, Germany
        • Research Site
      • Offenburg, Germany
        • Research Site
      • Oranienburg, Germany
        • Research Site
      • Osnabruck, Germany
        • Research Site
      • Paderborn, Germany
        • Research Site
      • Parchim, Germany
        • Research Site
      • Passau, Germany
        • Research Site
      • Peine, Germany
        • Research Site
      • Penzberg, Germany
        • Research Site
      • Pfinztal, Germany
        • Research Site
      • Pforzheim, Germany
        • Research Site
      • Pfullingen, Germany
        • Research Site
      • Pinneberg, Germany
        • Research Site
      • Pirmasens, Germany
        • Research Site
      • Plauen-Kauschwitz, Germany
        • Research Site
      • Pocking, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Quickborn, Germany
        • Research Site
      • Rahden, Germany
        • Research Site
      • Rangsdorf, Germany
        • Research Site
      • Ravensburg, Germany
        • Research Site
      • Recklinghausen, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Reinbek, Germany
        • Research Site
      • Remchingen, Germany
        • Research Site
      • Remscheid, Germany
        • Research Site
      • Rendsburg, Germany
        • Research Site
      • Reutlingen, Germany
        • Research Site
      • Rheine, Germany
        • Research Site
      • Rheinfelden, Germany
        • Research Site
      • Riebnitz-Damgarten, Germany
        • Research Site
      • Riesa, Germany
        • Research Site
      • Rodewisch, Germany
        • Research Site
      • Rodgau, Germany
        • Research Site
      • Rosenheim, Germany
        • Research Site
      • Rosrath, Germany
        • Research Site
      • Rotenburg, Germany
        • Research Site
      • Rottenburg, Germany
        • Research Site
      • Rottweil, Germany
        • Research Site
      • Saarbrucken, Germany
        • Research Site
      • Saarlouis, Germany
        • Research Site
      • Salzgitter, Germany
        • Research Site
      • Salzwedel, Germany
        • Research Site
      • Sandhausen, Germany
        • Research Site
      • Sayda, Germany
        • Research Site
      • Schalksmuhle, Germany
        • Research Site
      • Scheibenberg, Germany
        • Research Site
      • Schkeuditz, Germany
        • Research Site
      • Schleswig, Germany
        • Research Site
      • Schonaich, Germany
        • Research Site
      • Schonebeck, Germany
        • Research Site
      • Schorndorf, Germany
        • Research Site
      • Schwabach, Germany
        • Research Site
      • Schwabisch Hall, Germany
        • Research Site
      • Schwandorf, Germany
        • Research Site
      • Schweinfurt, Germany
        • Research Site
      • Schwerin, Germany
        • Research Site
      • Schwerte, Germany
        • Research Site
      • Schwetzingen, Germany
        • Research Site
      • Sebnitz, Germany
        • Research Site
      • Senden, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Simmern, Germany
        • Research Site
      • Singen (Hohentwiel), Germany
        • Research Site
      • Sogel, Germany
        • Research Site
      • Solingen, Germany
        • Research Site
      • Sommerda, Germany
        • Research Site
      • Spremberg, Germany
        • Research Site
      • Sprockhovel, Germany
        • Research Site
      • St. Wendel, Germany
        • Research Site
      • Starnberg, Germany
        • Research Site
      • Stendal, Germany
        • Research Site
      • Stockelsdorf, Germany
        • Research Site
      • Stralsund, Germany
        • Research Site
      • Stuhr, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
      • Sulzbach-Rosenberg, Germany
        • Research Site
      • Teltow, Germany
        • Research Site
      • Tettnang, Germany
        • Research Site
      • Torgau, Germany
        • Research Site
      • Tornesch, Germany
        • Research Site
      • Tubingen, Germany
        • Research Site
      • Uelzen, Germany
        • Research Site
      • Uetze, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Vechta, Germany
        • Research Site
      • Vechta-Langforden, Germany
        • Research Site
      • Veitshochheim, Germany
        • Research Site
      • Viersen, Germany
        • Research Site
      • Villingen-Schwenningen, Germany
        • Research Site
      • Vilsbiburg, Germany
        • Research Site
      • Vlotho, Germany
        • Research Site
      • Vohringen, Germany
        • Research Site
      • Volklingen, Germany
        • Research Site
      • Waldmunchen, Germany
        • Research Site
      • Walsrode, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
      • Warburg, Germany
        • Research Site
      • Warendorf, Germany
        • Research Site
      • Warin, Germany
        • Research Site
      • Wasserburg, Germany
        • Research Site
      • Weiden in der Oberpfalz, Germany
        • Research Site
      • Weingarten, Germany
        • Research Site
      • Wermelskirchen, Germany
        • Research Site
      • Werneck, Germany
        • Research Site
      • Wertheim, Germany
        • Research Site
      • Wetzlar, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Wilster, Germany
        • Research Site
      • Wismar, Germany
        • Research Site
      • Witten, Germany
        • Research Site
      • Witterda, Germany
        • Research Site
      • Wolfen, Germany
        • Research Site
      • Wolfsburg, Germany
        • Research Site
      • Worms, Germany
        • Research Site
      • Wuppertal, Germany
        • Research Site
      • Wurselen, Germany
        • Research Site
      • Wurzburg, Germany
        • Research Site
      • Zittau, Germany
        • Research Site
      • Zossen, Germany
        • Research Site
      • Zwickau, Germany
        • Research Site
      • Zwiesel, Germany
        • Research Site
      • Zwonitz, Germany
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.

Description

Inclusion Criteria:

  • Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
  • Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
  • Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
  • In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria:

  • Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
  • Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
  • Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
  • Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
All patients
treated with Anastrozole as per SPC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.
Time Frame: 12 months
12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
Time Frame: 12 months
12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.
Time Frame: 12 months
12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias
Time Frame: 12 months
12 months
Assessment of safety and tolerability of anastrozole.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: H Brasch, AstraZeneca, Germany

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-ODE-ARI-2008/1

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.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings