Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients
A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients
1 other identifier
interventional
2,021
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 1990
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedOctober 19, 2020
October 1, 2020
5.1 years
March 31, 2006
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Secondary Outcomes (2)
Recurrence-free survival
Side-effect profiles
Study Arms (2)
Group I
EXPERIMENTALTamoxifen alone
Group II
EXPERIMENTALTamoxifen + Aminoglutethimide
Interventions
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
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
Eligibility Criteria
You may qualify if:
- 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
- hematopoiesis: \> 3500/µl leucocytes, \> 100,000/µl thrombocytes
- renal function: creatinin \< 1.5mg%
- hepatic function: GOT \< 2.5 x UNL
- bilirubin: \< 1.5mg %
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Austrian Breast & Colorectal Cancer Study Grouplead
- AstraZenecacollaborator
Related Publications (4)
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.
PMID: 23511562BACKGROUNDSchmid 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.
PMID: 12637461BACKGROUNDRudas 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.
PMID: 18347178BACKGROUNDWimmer K, Hlauschek D, Balic M, Pfeiler G, Greil R, Singer CF, Halper S, Steger G, Suppan C, Gampenrieder SP, Helfgott R, Egle D, Filipits M, Jakesz R, Solkner L, Fesl C, Gnant M, Fitzal F. Is the CTS5 a helpful decision-making tool in the extended adjuvant therapy setting? Breast Cancer Res Treat. 2024 Jun;205(2):227-239. doi: 10.1007/s10549-023-07186-6. Epub 2024 Jan 25.
PMID: 38273214DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimund Jakesz, MD
Austrian Breast & Colorectal Cancer Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
December 1, 1990
Primary Completion
January 1, 1996
Study Completion
March 1, 2000
Last Updated
October 19, 2020
Record last verified: 2020-10