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Secondary Adjuvant Long Term Study With Arimidex (SALSA)
This study is ongoing, but not recruiting participants.

First Received on February 23, 2006.   Last Updated on December 22, 2010   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00295620
  Purpose

The study assesses the effect of a further 2 years vs a further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy.


Condition Intervention Phase
Breast Cancer
 Drug: Anastrozole
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of the effect in terms of DFS of 2 further years of anastrozole treatment vs further 5 years of adjuvant anastrozole treatment, following 5 years of adjuvant endocrine treatment [ Time Frame: throughout study (approx 15 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of overall survival rate, rate of fracture occurrence, occurrence of secondary carcinoma and contralateral breast cancer in the two treatment groups [ Time Frame: throughout study (approx 15 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 3486
Study Start Date: March 2004
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anastrozole
    1mg tablet daily
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No disease recurrence at time of randomization,
  • Patients with breast cancer after surgery,
  • 5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria:

  • Premenopausal patients,
  • Unknown or negative receptor status,
  • Secondary malignant tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295620

Locations
Austria
Research Site
Amstetten, Austria
Research Site
Bad Ischl, Austria
Research Site
Baden, Austria
Research Site
Bregenz, Austria
Research Site
Dornbirn, Austria
Research Site
Eisenstadt, Austria
Research Site
Feldbach, Austria
Research Site
Feldkirch, Austria
Research Site
Freistadt, Austria
Research Site
Furstenfeld, Austria
Research Site
Gmunden, Austria
Research Site
Graz, Austria
Research Site
Gussing, Austria
Research Site
Hainburg, Austria
Research Site
Hall in Tirol, Austria
Research Site
Innsbruck, Austria
Research Site
Judenburg-knittelfeld, Austria
Research Site
Kirchdorf, Austria
Research Site
Klagenfurt, Austria
Research Site
Krems, Austria
Research Site
Kufstein, Austria
Research Site
Leoben, Austria
Research Site
Lienz, Austria
Research Site
Linz, Austria
Research Site
Melk, Austria
Research Site
Mistelbach, Austria
Research Site
Modling, Austria
Research Site
Neunkirchen, Austria
Research Site
Oberpullendorf, Austria
Research Site
Oberwart, Austria
Research Site
Ried, Austria
Research Site
Rottenmann, Austria
Research Site
Salzburg, Austria
Research Site
Scheibbs, Austria
Research Site
Schladming, Austria
Research Site
Schwarzach, Austria
Research Site
St. Polten, Austria
Research Site
St. Veit/glan, Austria
Research Site
Steyr, Austria
Research Site
Villach, Austria
Research Site
Vocklabruck, Austria
Research Site
Waidhofen/thaya, Austria
Research Site
Wels-grieskirchen, Austria
Research Site
Wien, Austria
Research Site
Wiener Neustadt, Austria
Research Site
Wolfsberg, Austria
Research Site
Zams, Austria
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00295620     History of Changes
Other Study ID Numbers: D5392L00016, ABCSG 16, 1033AU/0003, SALSA
Study First Received: February 23, 2006
Last Updated: December 22, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AstraZeneca:
Hormone receptor positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Anastrozole
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012



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