ANZ 8613: A Phase III trial to evaluate additional versus substitution endocrine therapy in advanced breast cancer

Phase 3

Completed

• Conditions: Advanced breast cancer; Cancer - Breast

• Registration Number: ACTRN12607000096459
• Lead Sponsor: Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1994-11-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Established advanced breast cancer who have been receiving tamoxifen therapy for more than 6 months and have had documented progression of disease while on treatment and at least 6 months after beginning treatment. Key - Histologically confirmed primary breast cancer. - Progressive disease while on tamoxifen after at least 6 months of treatment with tamoxifen. - Objective evidence of evaluable or measurable recurrent, locally advanced and/or metastatic disease. - Post menopausal patients are eligible- Performance status of 3 or better (0-3), and survival expectation is at least three months. - Geographically accessible for follow-up- Informed consent obtained according to the standards required by the eithics and/or research committees of the participating institutions.

Exclusion Criteria

Past or current malignancy arising from sites other than the breast, except for adequately treated squamous or basal cell carcinoma of the skin, or in situ carcinoma of the cervix- Patients whose only demonstrable disease is intracranial- Prior treatment with MPA- Patients who only evidence of disease is asymptomatic abnormality on bone scan (ie plain x-ray does not demonstrate malignancy)Special consideration for eligibility may include:- Patients with established unequivocal oestrogen receptor (ER) negative status of metastatic and/or recurrent disease may be included- Patients with documented ER negative status of their original primary tumours are also eligible for this study- Patients who have relapsed on adjuvant tamoxifen or who have had prior tamoxifen adjuvant therapy are eligible for this trial provided they have been on tamoxifen for 6 months and are still receiving it at the time of entry to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified