Clinical trial · Interventional
Secondary Adjuvant Long Term Study With Arimidex
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
NCT00295620CI-TRIAL-00040951SALSAcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Anastrozol
- description
- 1 mg per day for 2 years
- interventionNames
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- Arm B: Anastrozol
- description
- 1 mg per day for 5 years
- interventionNames
- Drug: Anastrozole
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGnant 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 34320285