Secondary Adjuvant Long Term Study With Arimidex

Breast Cancer Clinical Trial

— SALSA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295620
• Other study ID #: 1033AU/0003
• Secondary ID: ABCSG 16D5392L00
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2004
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3484
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
1mg tablet daily

Locations

Country	Name	City	State
Austria	Research Site	Amstetten
Austria	Research Site	Bad Ischl
Austria	Research Site	Baden
Austria	Research Site	Bregenz
Austria	Research Site	Dornbirn
Austria	Research Site	Eisenstadt
Austria	Research Site	Feldbach
Austria	Research Site	Feldkirch
Austria	Research Site	Freistadt
Austria	Research Site	Fuerstenfeld
Austria	Research Site	Gmunden
Austria	Research Site	Graz
Austria	Research Site	Guessing
Austria	Research Site	Hainburg
Austria	Research Site	Hall in Tirol
Austria	Research Site	Innsbruck
Austria	Research Site	Kirchdorf
Austria	Research Site	Klagenfurt
Austria	Research Site	Klagenfurt
Austria	Research Site	Klagenfurt
Austria	Research Site	Krems
Austria	Research Site	Kufstein
Austria	Research Site	Leoben
Austria	Research Site	Lienz
Austria	Research Site	Linz
Austria	Research Site	Linz
Austria	Research Site	Mistelbach
Austria	Research Site	Moedling
Austria	Research Site	Neunkirchen
Austria	Research Site	Oberpullendorf
Austria	Research Site	Oberwart
Austria	Research Site	Ried im Innkreis
Austria	Research Site	Rottenmann
Austria	Research Site	Salzburg
Austria	Research Site	Scheibbs
Austria	Research Site	Schladming
Austria	Research Site	Schwarzach
Austria	Research Site	St. Poelten
Austria	Research Site	St. Veit an der Glan
Austria	Research Site	Steyr
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Austria	Research Site	Villach
Austria	Research Site	Villach
Austria	Research Site	Voecklabruck
Austria	Research Site	Waidhofen an der Thaya
Austria	Research Site	Weiz
Austria	Research Site	Wels
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wiener Neustadt
Austria	Research Site	Wolfsberg
Austria	Research Site	Zams

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	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).	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.
Secondary	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.	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
Secondary	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.	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

External Links

•   1033AU/0003 CSP redacted
•   1033AU/0003 SAP redacted