Secondary Adjuvant Long Term Study With Arimidex (SALSA)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00295620
First received: February 23, 2006
Last updated: June 5, 2012
Last verified: June 2012
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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 3 |
| 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
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 | |
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| Amstetten, Austria | |
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| Bad Ischl, Austria | |
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| Baden, Austria | |
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| Bregenz, Austria | |
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| Dornbirn, Austria | |
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| Eisenstadt, Austria | |
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| Feldbach, Austria | |
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| Feldkirch, Austria | |
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| Freistadt, Austria | |
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| Furstenfeld, Austria | |
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| Gmunden, Austria | |
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| Graz, Austria | |
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| Gussing, Austria | |
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| Hainburg, Austria | |
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| Hall in Tirol, Austria | |
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| Innsbruck, Austria | |
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| Judenburg-knittelfeld, Austria | |
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| Kirchdorf, Austria | |
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| Klagenfurt, Austria | |
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| Krems, Austria | |
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| Kufstein, Austria | |
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| Leoben, Austria | |
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| Lienz, Austria | |
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| Linz, Austria | |
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| Melk, Austria | |
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| Mistelbach, Austria | |
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| Modling, Austria | |
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| Neunkirchen, Austria | |
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| Oberpullendorf, Austria | |
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| Oberwart, Austria | |
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| Ried, Austria | |
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| Rottenmann, Austria | |
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| Salzburg, Austria | |
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| Scheibbs, Austria | |
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| Schladming, Austria | |
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| Schwarzach, Austria | |
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| St. Polten, Austria | |
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| St. Veit/glan, Austria | |
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| Steyr, Austria | |
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| Villach, Austria | |
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| Vocklabruck, Austria | |
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| Waidhofen/thaya, Austria | |
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| Wels-grieskirchen, Austria | |
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| Wien, Austria | |
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| Wiener Neustadt, Austria | |
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| Wolfsberg, Austria | |
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| Zams, Austria | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Austria Medical Director, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | 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: | June 5, 2012 |
| 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 May 19, 2013