Clinical trial · Interventional
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
NCT00309491CI-TRIAL-00047761completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen alone | Drug | — | UNRESOLVED |
| Tamoxifen + Aminoglutethimide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Tamoxifen alone
- interventionNames
- Drug: Tamoxifen alone
- type
- EXPERIMENTAL
- label
- Group II
- description
- Tamoxifen + Aminoglutethimide
- interventionNames
- Drug: Tamoxifen alone
- Drug: Tamoxifen + Aminoglutethimide
Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDPfeiler 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 23511562
- BACKGROUNDSchmid 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 12637461
- BACKGROUNDRudas 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 18347178
- DERIVEDWimmer 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 38273214