Clinical trial NCT00295620: Secondary Adjuvant Long Term Study With Arimidex
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Hormone receptor positive breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 3484
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Disease-free Survival After Prolonged Endocrine Treatment
timeFrame: 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:
measure: Overall Survival After Prolonged Endocrine Treatment
timeFrame: 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
measure: Time to First Clinical Fracture
timeFrame: 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.
measure: Time to Secondary Carcinoma
timeFrame: 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
measure: Time to Contralateral Breast Cancer
timeFrame: 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
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Research Site
city: Bad Ischl
country: Austria
facility: Research Site
city: Baden
country: Austria
facility: Research Site
city: Bregenz
country: Austria
facility: Research Site
city: Dornbirn
country: Austria
facility: Research Site
city: Eisenstadt
country: Austria
facility: Research Site
city: Feldbach
country: Austria
facility: Research Site
city: Feldkirch
country: Austria
facility: Research Site
city: Freistadt
country: Austria
facility: Research Site
city: Fuerstenfeld
country: Austria
facility: Research Site
city: Gmunden
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Guessing
country: Austria
facility: Research Site
city: Hainburg
country: Austria
facility: Research Site
city: Hall in Tirol
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Kirchdorf
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Krems
country: Austria
facility: Research Site
city: Kufstein
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Lienz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Mistelbach
country: Austria
facility: Research Site
city: Moedling
country: Austria
facility: Research Site
city: Neunkirchen
country: Austria
facility: Research Site
city: Oberpullendorf
country: Austria
facility: Research Site
city: Oberwart
country: Austria
facility: Research Site
city: Ried im Innkreis
country: Austria
facility: Research Site
city: Rottenmann
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Scheibbs
country: Austria
facility: Research Site
city: Schladming
country: Austria
facility: Research Site
city: Schwarzach
country: Austria
facility: Research Site
city: St. Poelten
country: Austria
facility: Research Site
city: St. Veit an der Glan
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Voecklabruck
country: Austria
facility: Research Site
city: Waidhofen an der Thaya
country: Austria
facility: Research Site
city: Weiz
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wiener Neustadt
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wolfsberg
country: Austria
facility: Research Site
city: Zams
country: Austria
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Austria Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.