Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Secondary Adjuvant Long Term Study With Arimidex (SALSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00295620
First received: February 23, 2006
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
The study assesses the effect of further 2 years vs 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: Treatment
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:


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 ]
    Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival


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 ]
    1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
    2. Comparison of fracture rate in both therapy groups
    3. Comparison of incidence of

      1. a secondary carcinoma except the contralateral mammacarcinoma
      2. contralateral mammacarcinoma in both therapie groups


Estimated Enrollment: 3500
Study Start Date: March 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Anastrozol
1 mg per day for 2 years
Drug: Anastrozole
1mg tablet daily
Other Name: Arimidex
Experimental: Arm B: Anastrozol
1 mg per day for 5 years
Drug: Anastrozole
1mg tablet daily
Other Name: Arimidex

Detailed Description:

ABCSG 16 S.A.L.S.A is assessing the effect of further 2 years vs further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy. S.A.L.S.A. is a randomized open multicentered phase III study comparing the efficacy of secondary adjuvant endokrine treatment of Arimidex® (Anastrozol) for 2 or 5 years after primary adjuvant endokrine therapy in patients with hormonreceptor positive mammakarzinom. Patients are examined at screening, after 6 months, then every year until 5 years. The subsequent yearly follow up with mammographie and clinical examination ends 10 years after the screening. S.A.L.S.A. started in February 2004 and has recruited 3484 patients until June 2010 at 78 sites all over Austria.

Primary Endpoint:

1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival

Secondary endpoint:

  1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
  2. Comparison of fracture rate in both therapy groups
  3. Comparison of incidence of

    1. a secondary carcinoma except the contralateral mammacarcinoma
    2. contralateral mammacarcinoma in both therapie groups
  Eligibility

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.
  2. No distant metastasis at randomization
  3. No relapse at randomization
  4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0
  5. Estrogen- and or progesterone positive before the beginningof primary endocrine therapy
  6. Endocrine therapy for 5 years (maximum deviation ±12 months)
  7. Therapy break (from the preliminary therapie) maximum 12 months.
  8. Informed Consent before the randomisation

Exclusion criteria:

  1. Premenopausal patients or patients with non definable menopausal statusat time of randomisation
  2. Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)
  3. General contraindication respectively hypersensitivity to Anastrozol.
  4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.
  5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy
  6. Known liver- and/or kidneyinsufficiency
  7. Performance Index >2 according to WHO
  8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma
  9. Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.
  10. Lacking compliance of the patient
  11. Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial
  12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Fuerstenfeld, Austria
Research Site
Gmunden, Austria
Research Site
Graz, Austria
Research Site
Guessing, Austria
Research Site
Hainburg, Austria
Research Site
Hall in Tirol, Austria
Research Site
Innsbruck, 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
Mistelbach, Austria
Research Site
Moedling, Austria
Research Site
Neunkirchen, Austria
Research Site
Oberpullendorf, Austria
Research Site
Oberwart, Austria
Research Site
Ried im Innkreis, Austria
Research Site
Rottenmann, Austria
Research Site
Salzburg, Austria
Research Site
Scheibbs, Austria
Research Site
Schladming, Austria
Research Site
Schwarzach, Austria
Research Site
St. Poelten, Austria
Research Site
St. Veit an der Glan, Austria
Research Site
Steyr, Austria
Research Site
Vienna, Austria
Research Site
Villach, Austria
Research Site
Voecklabruck, Austria
Research Site
Waidhofen an der Thaya, Austria
Research Site
Weiz, Austria
Research Site
Wels, Austria
Research Site
Wiener Neustadt, Austria
Research Site
Wien, Austria
Research Site
Wolfsberg, Austria
Research Site
Zams, Austria
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00295620     History of Changes
Other Study ID Numbers: 1033AU/0003  ABCSG 16  D5392L00016  SALSA 
Study First Received: February 23, 2006
Last Updated: September 15, 2016
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
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016