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.

Start:
01/2004
Randomizing ended:
30.6.2010

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

ABCSG-16 Design
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Studypurpose:

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

Inclusion criteria:

  1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinomwith 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 alcoholaddiction) et the time of admission into the study