ANZ 8811: A Phase III study to compare the effect of Zoladex depot (ICI 118,630) with Nolvadex plus Zoladex depot in pre- and peri-menopausal patients with advanced breast cancer.

Phase 3

Completed

• Conditions: Advanced breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000499583
• 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: 1994-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

a) Histologically or cytologically proven diagnosis of invasive primary breast cancer.b) Locally recurrent or locally advanced breast cancer (a locally advanced breast cancer which is 5cm diameter or greater on clinical measurement or fixed to the chest wall - T1b, T2b, T3b or T4) or distant metastases in bone, lung or soft tissue.c) One measurable or evaluable lesion.d) Pre or peri-menopausal women e) Informed consent to participate in the trial.

Exclusion Criteria

a) Adjuvant hormone or adjuvant anti-hormone therapy within the last 6 months.b) Adjuvant cytotoxic therapy within the last six months. Patients who are amenorrhoeic more than six months after adjuvant cytotoxic therapy should have menopausal status confirmed by serum levels of FSH.c) Prior therapy for advanced disease at any time.d) Concurrent invasive malignancy within the last five years.e) Pregnancyf) Pre-existing sex endocrine disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified