Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients

Early-stage Breast Cancer Clinical Trial

Official title:

A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309491
• Other study ID #: ABCSG-6
• Status: Completed
• Phase: Phase 3
• Start date: December 1990
• Est. completion date: March 2000

Study information

• Verified date: October 2020
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2021
• Est. completion date: March 2000
• Est. primary completion date: January 1996
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Drug:
• Tamoxifen alone
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
• Tamoxifen + 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	AstraZeneca

References & Publications (3)

Pfeiler G, Stöger 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Recurrence-free survival
Secondary	Side-effect profiles

External Links

•   Click here for more information about this study: publications