Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

Phase 1

Completed

• Conditions: Advanced Breast Cancer

• Registration Number: NCT00328120
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-04
• Study First Submitted: 2006-05-18
• Study First Submitted QC: 2006-05-18
• Study First Posted: 2006-05-19
• Study Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-16
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess the tolerability of 500mg fulvestrant	assessed when all patients have been in the study for 6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	each visit
Time to progression	assessed when all patients have been in the study for 6 months
ORR	assessed when all patients have been in the study for 6 months
Clinical benefit rate	assessed when all patients have been in the study for 6 months
Time to response	assessed when all patients have been in the study for 6 months
duration of response and changes in serum tumour markers	assessed when all patients have been in the study for 6 months

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan