Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

Advanced Breast Cancer Clinical Trial

Official title:

An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328120
• Other study ID #: D6995C00004
• Secondary ID: 9238IL/0062
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2006
• Last updated: November 16, 2010
• Start date: April 2004
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant
500 mg intramuscular injection

Locations

Country	Name	City	State
Japan	Research Site	Chiba
Japan	Research Site	Fukuoka
Japan	Research Site	Nagoyata
Japan	Research Site	Osaka
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics		each visit	No
Secondary	Time to progression		assessed when all patients have been in the study for 6 months	Yes
Secondary	ORR		assessed when all patients have been in the study for 6 months	Yes
Secondary	Clinical benefit rate		assessed when all patients have been in the study for 6 months	No
Secondary	Time to response		assessed when all patients have been in the study for 6 months	Yes
Secondary	duration of response and changes in serum tumour markers		assessed when all patients have been in the study for 6 months	Yes