Adjuvant Therapy for Postmenopausal Patients with Operable Breast Cancer who have Estrogen Receptor or Progesterone Receptor Positive Tumors.Tamoxifen vs. Letrozole vs. Tamoxifen followed by Letrozole vs. Letrozole followed by Tamoxife

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000012471
• Lead Sponsor: ovartis Pharma AG, Basel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 6193

Inclusion Criteria

Compliant postmenopausal women with histologically proven breast cancer who have had either a total mastectomy or a lesser procedure who are classified as pT1-3 or pT4b, Nx, Nsentinel-ve, N0-2, M0, and have oestrogen receptor and/or progesterone receptor positive tumours (ER/PR=10 fmol/mg cytosol protein or =10% of tumour cells positive by immunocytochemical assay); judged suitable for endocrine treatment; adequate marrow function, adequate renal and hepatic function; written and dated informed consent; geographically accessible for follow up; informed of data and material transfer and handling.

Exclusion Criteria

Patients with distant metastases. Bilateral breast cancer except in situ lesions of the contralateral breast. Patients with prior ipsilateral in situ breast cancer. Patients with previous history of concomitant other (not breast) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous malignancy must have been disease free for five years. Patients receiving adjuvant chemotherapy at randomisation. Patients with other non-malignant systemic diseases. Patients treated with systemic investigational drugs within the past 30 days or topical investigational drugs within the past 7 days. History of non-compliance to medical regimens and patients who are considered potentially unreliable. Patients known to be HIV positive.

Study & Design

• Study Type: Interventional
• Study Design: Not specified