Status:
COMPLETED
Secondary Adjuvant Long Term Study With Arimidex
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
3484 Patients enrolled
Trial Details
Trial ID
NCT00295620
Start Date
March 1 2004
End Date
June 30 2017
Last Update
October 2 2019
Active Locations (60)
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1
Research Site
Amstetten, Austria, 3300
2
Research Site
Bad Ischl, Austria, 4820
3
Research Site
Baden, Austria, 2500
4
Research Site
Bregenz, Austria, 6900