Early-stage Breast Cancer
Conditions
Keywords
Tamoxifen, Aminoglutethimide, Breast cancer
Brief summary
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
Interventions
DRUGTamoxifen alone
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
DRUGTamoxifen + Aminoglutethimide
2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years) * 1st therapy week:125mg/-/125mg Aminoglutethimide daily * 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily * as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily
Sponsors
AstraZeneca
Austrian Breast & Colorectal Cancer Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer * Hormone receptor-positive status * More than 6 histologically examined lymph nodes * Laboratory parameters 1. hematopoiesis: \> 3500/µl leucocytes, \> 100,000/µl thrombocytes 2. renal function: creatinin \< 1.5mg% 3. hepatic function: GOT \< 2.5 x UNL 4. bilirubin: \< 1.5mg % 5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar * Concluded healing process following surgery * Less than 4 weeks interval since surgery * Informed consent
Exclusion criteria
* Premenopausal patients, non-determinable menopausal status * Previous radiotherapy, chemotherapy or endocrine treatment * Generalized disease (as verified by lung X-ray, skeletal X-ray, liver ultrasound) * Contraindications against tamoxifen or anastrozole * T4 tumors; carcinoma in situ * Lacking compliance or understanding of disease * Karnofsky Index \< 3 * Serious concomitant disease * Septic complications, systemic infections or infectious local processes * Bilateral ovariectomy or ovarian irradiation * Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | — |
| Side-effect profiles | — |
Outcome results
None listed