Clinical trial NCT00309491: Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients
Official title: A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early-stage Breast Cancer
Keywords: Tamoxifen
Aminoglutethimide
Breast cancer
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: AstraZeneca
First posted: 2006-04-03
Enrollment: 2021
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Recurrence-free survival
measure: Side-effect profiles
Other outcomes:
Locations:
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfeiler G, Stoger H, Dubsky P, Mlineritsch B, Singer C, Balic M, Fitzal F, Moik M, Kwasny W, Selim U, Renner K, Ploner F, Steger GG, Seifert M, Hofbauer F, Sandbichler P, Samonigg H, Jakesz R, Greil R, Fesl C, Gnant M; ABCSG. Efficacy of tamoxifen +/- aminoglutethimide in normal weight and overweight postmenopausal patients with hormone receptor-positive breast cancer: an analysis of 1509 patients of the ABCSG-06 trial. Br J Cancer. 2013 Apr 16;108(7):1408-14. doi: 10.1038/bjc.2013.114. Epub 2013 Mar 19.
citation: Schmid M, Jakesz R, Samonigg H, Kubista E, Gnant M, Menzel C, Seifert M, Haider K, Taucher S, Mlineritsch B, Steindorfer P, Kwasny W, Stierer M, Tausch C, Fridrik M, Wette V, Steger G, Hausmaninger H. Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: Austrian breast and colorectal cancer study group trial 6. J Clin Oncol. 2003 Mar 15;21(6):984-90. doi: 10.1200/JCO.2003.01.138.
citation: Rudas M, Lehnert M, Huynh A, Jakesz R, Singer C, Lax S, Schippinger W, Dietze O, Greil R, Stiglbauer W, Kwasny W, Grill R, Stierer M, Gnant MF, Filipits M; Austrian Breast and Colorectal Cancer Study Group. Cyclin D1 expression in breast cancer patients receiving adjuvant tamoxifen-based therapy. Clin Cancer Res. 2008 Mar 15;14(6):1767-74. doi: 10.1158/1078-0432.CCR-07-4122.