NCT00295620: SALSA

Secondary Adjuvant Long Term Study With Arimidex

Completed Phase 3 Results posted Last updated 2 October 2019

What this trial tests

Phase 3 trial testing Anastrozole in Breast Cancer in 3,484 participants. Completed in 30 June 2017.

Timeline

1 March 2004

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3,484
Start date	1 March 2004
Primary completion	30 June 2017
Estimated completion	30 June 2017
Sites	60 locations across Austria

Drugs / interventions tested

• Anastrozole (anastrozole) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease-free Survival After Prolonged Endocrine Treatment Primary · 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.

Group	Value	95% CI
Arm A: Anastrozol	NA	7.7 – NA
Arm B: Anastrozol	NA	8.1 – NA

Overall Survival After Prolonged Endocrine Treatment Secondary · 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.

Group	Value	95% CI
Arm A: Anastrozol	NA	NA – NA
Arm B: Anastrozol	NA	NA – NA

Time to First Clinical Fracture Secondary · 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).

Group	Value	95% CI
Arm A: Anastrozol	NA	NA – NA
Arm B: Anastrozol	NA	NA – NA

Time to Secondary Carcinoma Secondary · 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.

Group	Value	95% CI
Arm A: Anastrozol	NA	NA – NA
Arm B: Anastrozol	NA	NA – NA

Time to Contralateral Breast Cancer Secondary · 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.

Group	Value	95% CI
Arm A: Anastrozol	NA	NA – NA
Arm B: Anastrozol	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm B: Anastrozol - 1 mg Per Day for 5 Years

Serious: 687/1710 (40%)

Deaths: 207/1738

Arm A: Anastrozol - 1 mg Per Day for 2 Years

Serious: 452/1705 (27%)

Deaths: 207/1732

Serious adverse events (775 terms)

Reaction	System	Arm B: Anastrozol - 1 mg P…	Arm A: Anastrozol - 1 mg P…
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—
Cataract	Eye disorders	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—
Atrial fibrillation	Cardiac disorders	—	—
Large intestine polyp	Gastrointestinal disorders	—	—
Endometrial hyperplasia	Reproductive system and breast disorders	—	—
Uterine polyp	Reproductive system and breast disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—
Meniscus injury	Injury, poisoning and procedural complications	—	—
Foot deformity	Musculoskeletal and connective tissue disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Hypertensive crisis	Vascular disorders	—	—
Goitre	Endocrine disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Varicose vein	Vascular disorders	—	—
Pneumonia	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Postmenopausal haemorrhage	Reproductive system and breast disorders	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Carpal tunnel syndrome	Nervous system disorders	—	—

Most-reported serious reactions: Osteoarthritis, Radius fracture, Cataract, Ankle fracture, Atrial fibrillation, Large intestine polyp, Endometrial hyperplasia, Uterine polyp.

Data from ClinicalTrials.gov NCT00295620 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer.
   Gnant M, Fitzal F, Rinnerthaler G, Steger GG, et al · · 2021 · cited 109× · PMID 34320285 · DOI 10.1056/nejmoa2104162
2. CYP2D6 metabolism and patient outcome in the Austrian Breast and Colorectal Cancer Study Group trial (ABCSG) 8.
   Goetz MP, Suman VJ, Hoskin TL, Gnant M, et al · · 2013 · cited 91× · PMID 23213055 · DOI 10.1158/1078-0432.ccr-12-2153
3. Status of adjuvant endocrine therapy for breast cancer.
   Schiavon G, Smith IE. · · 2014 · cited 53× · PMID 25032258 · DOI 10.1186/bcr3636
4. Current Status of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer.
   van Hellemond IEG, Geurts SME, Tjan-Heijnen VCG. · · 2018 · cited 35× · PMID 29704066 · DOI 10.1007/s11864-018-0541-1
5. Impact of CDK4/6 Inhibitors on Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in the Adjuvant Setting.
   Skafida E, Andrikopoulou A, Terpos E, Markellos C, et al · · 2023 · cited 8× · PMID 37293258 · DOI 10.1155/2023/3614296
6. Adjuvant endocrine treatment strategies for non-metastatic breast cancer: a network meta-analysis.
   Papakonstantinou A, Villacampa G, Navarro V, Oliveira M, et al · · 2025 · cited 7× · PMID 40034565 · DOI 10.1016/j.eclinm.2025.103116
7. Multiomics plasma effects of switching from triple antiretroviral regimens to dolutegravir plus lamivudine.
   de Lazzari E, Negredo EB, Domingo P, Tiraboschi JM, et al · · 2024 · cited 5× · PMID 38546974 · DOI 10.1093/jac/dkae083
8. Extended Adjuvant Endocrine Therapy in Hormone Receptor-Positive Early Breast Cancer.
   Bracken-Clarke DB, Lucas MW, Higgins MJ. · · 2017 · cited 1× · PMID 28785180 · DOI 10.1159/000477956