Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. (ARNO-95)

This study has been completed.
Sponsor:
Collaborator:
German Adjuvant Breast Cancer Group
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00287534
First received: February 6, 2006
Last updated: June 7, 2009
Last verified: June 2009

February 6, 2006
June 7, 2009
November 1996
Not Provided
To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
Same as current
Complete list of historical versions of study NCT00287534 on ClinicalTrials.gov Archive Site
  • To assess difference in overall survival between the two treatment arms
  • To assess difference in disease recurrence between the two treatment arms
  • To assess difference in safety and tolerability between the two treatment arms
Same as current
Not Provided
Not Provided
 
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Anastrozole
    oral
    Other Names:
    • Arimidex
    • ZD1033
  • Drug: Tamoxifen
    oral
    Other Name: Nolvadex
  • Experimental: 1
    Anastrozole
    Intervention: Drug: Anastrozole
  • Active Comparator: 2
    Tamoxifen
    Intervention: Drug: Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1059
September 2004
Not Provided

Inclusion Criteria:

  • Signed informed consent,
  • Post-menopausal women ≤75 years,
  • histologically confirmed invasive breast carcinoma (no distant metastases),
  • positive hormone receptor status,
  • continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery

Exclusion Criteria:

  • menopause status maintained by medication,
  • pre-operative chemotherapy or hormone therapy or radiation therapy,
  • relapse or second carcinoma or previous cancerous disease,
  • breast carcinoma in situ,
  • simultaneous carcinoma of the opposite side or secondary breast,
  • 10 or more tumour-infiltrated lymph nodes.
  • serious accompanying diseases
Female
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00287534
1033GR/0001, ARNO-95
Not Provided
Not Provided
AstraZeneca
German Adjuvant Breast Cancer Group
Principal Investigator: Manfred Kaufmann, MD German Adjuvant Breast Cancer Group
AstraZeneca
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP