Secondary Adjuvant Long Term Study With Arimidex (SALSA)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00295620

SALSA

1033AU/0003

ABCSG 16

D5392L00016

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,484 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,484 participants in 2 patient groups

Arm A: Anastrozol

Experimental group

Description:

1 mg per day for 2 years

Treatment:

Drug: Anastrozole

Arm B: Anastrozol

Experimental group

Description:

1 mg per day for 5 years

Treatment:

Drug: Anastrozole