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Completed

NCT Number: NCT00309491

Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal 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.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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)

Treatment and study plan

Tamoxifen alone

Drug

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

Other names: Nolvadex

Tamoxifen + Aminoglutethimide

Drug

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

Other names: Nolvadex + Orimeten

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Recurrence-free survival

  2. Side-effect profiles

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
1990
Primary completion
1996
Study completion
2000
First posted
Apr 3, 2006
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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