Secondary Adjuvant Long Term Study With Arimidex
SALSA
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
4 other identifiers
interventional
3,484
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Mar 2004
Longer than P75 for phase_3 breast-cancer
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedResults Posted
Study results publicly available
October 2, 2019
CompletedOctober 2, 2019
October 1, 2019
13.3 years
February 23, 2006
December 14, 2018
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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 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
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
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
Study Arms (2)
Arm A: Anastrozol
EXPERIMENTAL1 mg per day for 2 years
Arm B: Anastrozol
EXPERIMENTAL1 mg per day for 5 years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Amstetten, 3300, Austria
Research Site
Bad Ischl, 4820, Austria
Research Site
Baden, 2500, Austria
Research Site
Bregenz, 6900, Austria
Research Site
Dornbirn, 6853, Austria
Research Site
Eisenstadt, 7000, Austria
Research Site
Feldbach, 8330, Austria
Research Site
Feldkirch, 6807, Austria
Research Site
Freistadt, 4240, Austria
Research Site
Fürstenfeld, 8280, Austria
Research Site
Gmunden, 4810, Austria
Research Site
Graz, 8036, Austria
Research Site
Güssing, 7540, Austria
Research Site
Hainburg an der Donau, 2410, Austria
Research Site
Hall in Tirol, 6060, Austria
Research Site
Innsbruck, 6020, Austria
Research Site
Kirchdorf, 4560, Austria
Research Site
Klagenfurt, 8020, Austria
Research Site
Klagenfurt, 9020, Austria
Research Site
Klagenfurt, 9026, Austria
Research Site
Krems, 3500, Austria
Research Site
Kufstein, 6330, Austria
Research Site
Leoben, 8700, Austria
Research Site
Lienz, 9900, Austria
Research Site
Linz, 4010, Austria
Research Site
Linz, 4021, Austria
Research Site
Mistelbach, 2130, Austria
Research Site
Mödling, 2340, Austria
Research Site
Neunkirchen, 2620, Austria
Research Site
Oberpullendorf, 7350, Austria
Research Site
Oberwart, 7400, Austria
Research Site
Ried im Innkreis, 4910, Austria
Research Site
Rottenmann, 8786, Austria
Research Site
Salzburg, 5020, Austria
Research Site
Sankt Pölten, 3100, Austria
Research Site
Sankt Veit an der Glan, 9300, Austria
Research Site
Scheibbs, 3270, Austria
Research Site
Schladming, 8970, Austria
Research Site
Schwarzach, 5620, Austria
Research Site
Steyr, 4400, Austria
Research Site
Vienna, 1021, Austria
Research Site
Vienna, 1050, Austria
Research Site
Vienna, 1070, Austria
Research Site
Vienna, 1090, Austria
Research Site
Vienna, 1130, Austria
Research Site
Vienna, 1140, Austria
Research Site
Vienna, 1160, Austria
Research Site
Vienna, 1180, Austria
Research Site
Vienna, 1210, Austria
Research Site
Vienna, 1220, Austria
Research Site
Vienna, A-1090, Austria
Research Site
Villach, 9500, Austria
Research Site
Villach, 9504, Austria
Research Site
Vöcklabruck, 4840, Austria
Research Site
Waidhofen an der Thaya, 3830, Austria
Research Site
Weiz, 8160, Austria
Research Site
Wels, 4600, Austria
Research Site
Wiener Neustadt, 2700, Austria
Research Site
Wolfsberg, 9400, Austria
Research Site
Zams, 6511, Austria
Related Publications (1)
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.
PMID: 34320285DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Office Director
- Organization
- ABCSG
Study Officials
- STUDY DIRECTOR
AstraZeneca Austria Medical Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 24, 2006
Study Start
March 1, 2004
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
October 2, 2019
Results First Posted
October 2, 2019
Record last verified: 2019-10