A Phase III Study to Evaluate Letrozole as Adjuvant Endocrina Therapy for Postmenopausal Women with Receptor (ER and/or PgR) Positive Tumors

Not Applicable

• Conditions: -C509 Breast, unspecified; Breast, unspecified; C509

• Registration Number: PER-051-00
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-09-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Compliant postmenopausal women with operable breast cancer (adenocarcinoma of the breast)
•Operable breast cancer
•Following surgery, eligible patients will be classified as pTl, pT2, pT3, or pT4b (patients whose tumors have minimal dermal involvement on pathology only)
•Patients must be judged suitable for treatment with endocrine therapy
•Adequate marrow function (WBC>3.0 x 10 9/L, platelets> 100 x 10 9/L, and hemoglobin >10 g/dL).
•Documented evidence of adequate renal function (creatinine < 180 pmol/L) and hepatic function (bilirubin < 30 umol/L, ALT (SGPT) or AST (SGOT) < 1.5 x upper limit of the institution).
•Written and dated informed consent.
•Must be geographically accessible for follow-up.
•Patients must be informed of data and material transfer and handling, in accordance with national data protection guidelines.

Exclusion Criteria

•Patients with previous or concomitant other (not breast cancer) 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 other malignancy must have been disease free for five years.
•Patients receiving adjuvant chemotherapy at randomization. Patients may plan to begin adjuvant chemotherapy ai the same time as protocol therapy, or patients may have completed adjuvant chemotherapy.
•Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. Patients with previous DVT can be included only if medically suitable.
•Patients treated with systemic investigational drugs within the past 30 days or topical investigational drugs within the past 7 days.
•History of noncompliance to medical regimens and patients who are considered potentially unreliable.
•Patients known to be HIV positive (No specific tests are required to determine the eligibility).

Study & Design

• Study Type: Interventional
• Study Design: Not specified