Breast CancerPhase 3SALSANCT00295620

Secondary Adjuvant Long Term Study With Arimidex

A Phase 3 study testing Anastrozole in people with Breast Cancer, run by AstraZeneca at 60 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Anastrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,484 participants
Where: 60 sitesAustria
Study dates: 1 Mar 2004to 30 Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Premenopausal patients or patients with non definable menopausal statusat time of randomisation
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)
General contraindication respectively hypersensitivity to Anastrozol.
In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.
Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy
Known liver- and/or kidneyinsufficiency

Show all 12Show fewer

Performance Index >2 according to WHO
Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma
Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.
Lacking compliance of the patient
Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial
Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

Austria60 sites

Research Site
Amstetten, 3300
Research Site
Bad Ischl, 4820
Research Site
Baden, 2500
Research Site
Bregenz, 6900
Research Site
Dornbirn, 6853
Research Site
Eisenstadt, 7000
Research Site
Feldbach, 8330
Research Site
Feldkirch, 6807
Research Site
Freistadt, 4240
Research Site
Fürstenfeld, 8280
Research Site
Gmunden, 4810
Research Site
Graz, 8036
Research Site
Guessing, 7540
Research Site
Hainburg an der Donau, 2410
Research Site
Hall in Tirol, 6060
Research Site
Innsbruck, 6020
Research Site
Kirchdorf, 4560
Research Site
Klagenfurt, 8020
Research Site
Klagenfurt, 9020
Research Site
Klagenfurt, 9026
Research Site
Krems, 3500
Research Site
Kufstein, 6330
Research Site
Leoben, 8700
Research Site
Lienz, 9900
Research Site
Linz, 4010
Research Site
Linz, 4021
Research Site
Mistelbach, 2130
Research Site
Mödling, 2340
Research Site
Neunkirchen, 2620
Research Site
Oberpullendorf, 7350
Research Site
Oberwart, 7400
Research Site
Ried im Innkreis, 4910
Research Site
Rottenmann, 8786
Research Site
Salzburg, 5020
Research Site
Sankt Pölten, 3100
Research Site
Sankt Veit an der Glan, 9300
Research Site
Scheibbs, 3270
Research Site
Schladming, 8970
Research Site
Schwarzach, 5620
Research Site
Steyr, 4400
Research Site
Vienna, 1021
Research Site
Vienna, 1050
Research Site
Vienna, 1070
Research Site
Vienna, 1090
Research Site
Vienna, 1130
Research Site
Vienna, 1140
Research Site
Vienna, 1160
Research Site
Vienna, 1180
Research Site
Vienna, 1210
Research Site
Vienna, 1220
Research Site
Vienna, A-1090
Research Site
Villach, 9500
Research Site
Villach, 9504
Research Site
Vöcklabruck, 4840
Research Site
Waidhofen an der Thaya, 3830
Research Site
Weiz, 8160
Research Site
Wels, 4600
Research Site
Wiener Neustadt, 2700
Research Site
Wolfsberg, 9400
Research Site
Zams, 6511

Other trials in Austria

About this study

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

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.

Read the 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:

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:

Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
Comparison of fracture rate in both therapy groups
Comparison of incidence of
a secondary carcinoma except the contralateral mammacarcinoma
contralateral mammacarcinoma in both therapie groups

Conditions: Breast Cancer
Being tested: Anastrozole
Keywords: Hormone receptor positive breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnastrozoleDrug
Also called Arimidex
1mg tablet daily

Study groups in NCT00295620
Study group	Role	What they receive
Arm A: Anastrozol	Experimental	1 mg per day for 2 years Receives: Drug: Anastrozole
Arm B: Anastrozol	Experimental	1 mg per day for 5 years Receives: Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free Survival After Prolonged Endocrine Treatment
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.
Measured: 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

Secondary outcomes (4)

Overall Survival After Prolonged Endocrine Treatment
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.
Measured: 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
Time to First Clinical Fracture
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).
Measured: 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.
Time to Secondary Carcinoma
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.
Measured: 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
Time to Contralateral Breast Cancer
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 200430 Jun 2017

First posted24 Feb 2006 (estimated)
Study start1 Mar 2004
Primary completion30 Jun 2017
Study completion30 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00295620
Sponsor's protocol ID: 1033AU/0003
Other IDs: ABCSG 16, D5392L00016, SALSA
Acronym: SALSA
Status last verified: Oct 2019
First submitted: 23 Feb 2006
Last updated: 2 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, Heck D, Jakesz R, Thaler J, Egle D, Manfreda D, Bjelic-Radisic V, Wieder U, Singer CF, Melbinger-Zeinitzer E, Haslbauer F, Sevelda P, Trapl H, Wette V, Wimmer K, Gampenrieder SP, Bartsch R, Kacerovsky-Strobl S, Suppan C, Brunner C, Deutschmann C, Soelkner L, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group. Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer. N Engl J Med. 2021 Jul 29;385(5):395-405. doi: 10.1056/NEJMoa2104162.
PubMed 34320285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00295620
Acronym / sponsor ID: SALSA / 1033AU/0003
Conditions: Breast Cancer
Keywords: Hormone receptor positive breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,484 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Mar 2004 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 24 Feb 2006 (estimated)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Primary Endpoint:

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:

Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
Comparison of fracture rate in both therapy groups
Comparison of incidence of
a secondary carcinoma except the contralateral mammacarcinoma
contralateral mammacarcinoma in both therapie groups

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Anastrozol	Experimental	Drug: Anastrozole1 mg per day for 2 years
Arm B: Anastrozol	Experimental	Drug: Anastrozole1 mg per day for 5 years

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.
No distant metastasis at randomization
No relapse at randomization
TNM- classification at time of diagnosis: T1-3, N0 and N+, M0
Estrogen- and or progesterone positive before the beginningof primary endocrine therapy

Key exclusion criteria (12 listed)

Premenopausal patients or patients with non definable menopausal statusat time of randomisation
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)
General contraindication respectively hypersensitivity to Anastrozol.
In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.
Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AnastrozoleAlso: Arimidex1mg tablet daily	Drug	Arm A: Anastrozol, Arm B: Anastrozol

Primary outcome

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.

4 secondary outcomes

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
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.
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
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

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Anastrozol	1,732	860
Arm B: Anastrozol	1,738	842

Primary outcome: 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. Median (Inter-Quartile Range). Unit: Years

Measure	Arm A: Anastrozol n = 1281	Arm B: Anastrozol n = 1323
Value	NA (7.7 to NA)	NA (8.1 to NA)

Arm A: Anastrozol vs Arm B: Anastrozol: Hazard Ratio (HR): 0.93 (95% CI 0.79 to 1.11), p = 0.425, Log Rank

Population analysed: Per-Protocol (PP) Population, defined as all randomized patients who signed the informed consent who complied with the inclusion and exclusion criteria, who had at least one follow-up examination after randomization and who survived without recurrence for two years.

4 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm B: Anastrozol - 1 mg Per Day for 5 Years	687 of 1,710 (40.2%)	0 of 1,710 (0%)	207 of 1,738
Arm A: Anastrozol - 1 mg Per Day for 2 Years	452 of 1,705 (26.5%)	0 of 1,705 (0%)	207 of 1,732

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34320285Gnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, Heck D, Jakesz R, Thaler J, Egle D, Manfreda D, Bjelic-Radisic V, Wieder U, Singer CF, Melbinger-Zeinitzer E, Haslbauer F, Sevelda P, Trapl H, Wette V, Wimmer K, Gampenrieder SP, Bartsch R, Kacerovsky-Strobl S, Suppan C, Brunner C, Deutschmann C, Soelkner L, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group. Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer. N Engl J Med. 2021 Jul 29;385(5):395-405. doi: 10.1056/NEJMoa2104162.
1033AU/0003 CSP redactedLink provided by the sponsor.
1033AU/0003 SAP redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Austria Medical Director, MD study director

AstraZeneca

60 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anastrozole in people with Breast Cancer, run by AstraZeneca at 60 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.