BEECH

Phase 1

• Conditions: Advanced or Metastatic Breast Cancer, ER+ve Advanced or Metastatic Breast Cancer

• Registration Number: JPRN-jRCT2080222418
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Provision of informed consent.

-Histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be ER+ve, HER2-ve, in Part B).

-World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.

Exclusion Criteria

-Clinically significant abnormalities of glucose metabolism.

-Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).

-Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

-Any prior exposure to agents which inhibit AKT as the primary pharmacological activity.

-Part A: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer. Part B: any prior chemotherapy for advanced or metastatic breast cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified