AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Estradiol; Estrogens; Fulvestrant

Criteria

Inclusion Criteria:

• Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis

• Aged at least 18

• At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment

• Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Patients must have evidence of non-child-bearing potential.

Exclusion Criteria:

• Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)

• Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.

• Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.

• Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)