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.


Phase 2
N/A
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Manfred Kaufmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

German Adjuvant Breast Cancer Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

1033GR/0001

NCT ID:

NCT00287534

Start Date:

November 1996

Completion Date:

September 2004

Related Keywords:

  • Breast Cancer
  • Early Breast Cancer
  • Breast Neoplasms
  • Carcinoma

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