Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Breast Cancer

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00328120

9238IL/0062

D6995C00004

Details and patient eligibility

About

The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• Postmenopausal woman who fulfils any one of the following criteria:
• Histological or cytological confirmation of breast cancer
• Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion criteria

• Having received any one of the following therapy for advanced or recurrent breast cancer
• 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)