Status:

COMPLETED

Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

German Adjuvant Breast Cancer Group

Conditions:

Breast Cancer

Eligibility:

FEMALE

Up to 75 years

Phase:

PHASE2

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 1996

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2004

Estimated Enrollment :

1059 Patients enrolled

Trial Details

Trial ID

NCT00287534

Start Date

November 1 1996

End Date

September 1 2004

Last Update

June 9 2009

Active Locations (43)

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Page 1 of 11 (43 locations)

1

Research Site

Albstadt, Germany

2

Research Site

Berlin, Germany

3

Research Site

Cloppenburg, Germany

4

Research Site

Eggenfelden, Germany

Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. | DecenTrialz