ABCSG 16/S.A.L.S.A Details
A prospective, randomized, open-label, multi-center, phase-II-study evaluating the effect of a secondary adjuvant endocrine therapy with anastrozole for 2 years vs. 5 years in patients with hormone-receptor-positive breast cancer after 5 years prior adjuvant endocrine therapy.
- Randomizing ended:
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- Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival
- Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
- Comparison of fracture rate in both therapy groups
- Comparison of incidence of
- a secondary carcinoma except the contralateral mammacarcinoma
- contralateral mammacarcinoma
in both therapie groups
- Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinomwith 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
- 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 alcoholaddiction) et the time of admission into the study