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Early-stage Breast CancerPhase 3NCT00309491

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

A Phase 3 study testing Tamoxifen alone and Tamoxifen + Aminoglutethimide in people with Early-stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 80 years, women only
Conditions the study is for
Early-stage Breast Cancer
What is being tested?
Tamoxifen alone and Tamoxifen + Aminoglutethimide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,021 participants
Where
No sites listed yet
Study dates
Dec 1990to Mar 2000
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

About this study

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

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.

Being tested
Tamoxifen alone, Tamoxifen + Aminoglutethimide
Keywords
Tamoxifen, Aminoglutethimide, Breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tamoxifen aloneDrug

    Also called Nolvadex

    2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years

  • Tamoxifen + AminoglutethimideDrug

    Also called Nolvadex + Orimeten

    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
Study groups in NCT00309491
Study groupRoleWhat they receive
Group IExperimentalTamoxifen alone
Receives: Drug: Tamoxifen alone
Group IIExperimentalTamoxifen + Aminoglutethimide
Receives: Drug: Tamoxifen alone; Drug: Tamoxifen + Aminoglutethimide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (2)

  1. Recurrence-free survival

  2. Side-effect profiles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2006 (estimated)
  2. Study startDec 1990
  3. Primary completionJan 1996
  4. Study completionMar 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,021 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309491
Sponsor's protocol ID
ABCSG-6
Status last verified
Oct 2020
First submitted
31 Mar 2006
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23511562

  • 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.

    PubMed 12637461

  • 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.

    PubMed 18347178

  • Wimmer 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.

    PubMed 38273214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tamoxifen alone and Tamoxifen + Aminoglutethimide in people with Early-stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309491, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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