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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
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 1, 2004
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Disease-free Survival After Prolonged Endocrine Treatment [ Time Frame: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years ]
    To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.


Secondary Outcome Measures :
  1. Overall Survival After Prolonged Endocrine Treatment [ Time Frame: Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years ]
    To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.

  2. Time to First Clinical Fracture [ Time Frame: Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient. ]
    To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).

  3. Time to Secondary Carcinoma [ Time Frame: Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years ]
    To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.

  4. Time to Contralateral Breast Cancer [ Time Frame: Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years ]
    To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295620


Locations
Show Show 62 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] November 27, 2009
Statistical Analysis Plan  [PDF] August 28, 2017

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00295620    
Other Study ID Numbers: 1033AU/0003
ABCSG 16
D5392L00016
SALSA
First Posted: February 24, 2006    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: October 2019
Keywords provided by AstraZeneca:
Hormone receptor positive breast cancer
Additional relevant MeSH terms:
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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