IBCSG 32-05 / BIG 1-05 - Chemotherapy Adjuvant Study for women at advanced age

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000077561
• Lead Sponsor: Australian New Zealand Breast Cancer Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1296

Inclusion Criteria

Histologically proven, hormone receptor negative, completely resected breast cancer confined to the breast and axillary nodes without detected metastases elsewhere; patients must not be candidates for endocrine therapy or standard chemotherapy regimen; margins must be negative for invasive breast cancer and DCIS; adequate bone marrow, renal, and hepatic function; adequate cardiovascular function and geographically accessible for follow-up.

Exclusion Criteria

Patients with locally advanced inoperable breast cancer; patients with a history of any prior ipsilateral or contralateral invasive breast cancer; patients with previous or concomitant malignancy diagnosed within the past five years; patients with other non-malignant uncontrolled systemic diseases; patients with myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomisation; patients with significant malabsorption syndrome or disease affecting gastrointestinal tract function; prior neoadjuvant or adjuvant therapy for breast cancer; hormone replacement therapy (HRT); hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions; treatment with bisphosphonates, except for the treatment of osteoporosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified