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Secondary Adjuvant Long Term Study With Arimidex (SALSA)

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ClinicalTrials.gov Identifier: NCT00295620
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

February 23, 2006
February 24, 2006
March 13, 2018
March 1, 2004
June 30, 2017   (Final data collection date for primary outcome measure)
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) ]
Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival
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
Complete list of historical versions of study NCT00295620 on ClinicalTrials.gov Archive Site
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) ]
  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
Assessment of overall survival rate, rate of fracture occurrence, occurrence of secondary carcinoma and contralateral breast cancer in the two treatment groups
Not Provided
Not Provided
 
Secondary Adjuvant Long Term Study With Arimidex
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
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.

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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Anastrozole
1mg tablet daily
Other Name: Arimidex
  • Experimental: Arm A: Anastrozol
    1 mg per day for 2 years
    Intervention: Drug: Anastrozole
  • Experimental: Arm B: Anastrozol
    1 mg per day for 5 years
    Intervention: Drug: Anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3486
3500
June 30, 2017
June 30, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00295620
1033AU/0003
ABCSG 16
D5392L00016
SALSA
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca
AstraZeneca
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP