Faslodex 500mg Multiple Dose Tolerability Study in BC Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00328120

Purpose

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

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Fulvestrant	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to assess the tolerability of 500mg fulvestrant [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: each visit ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
ORR [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
Clinical benefit rate [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: No ]
Time to response [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]
duration of response and changes in serum tumour markers [ Time Frame: assessed when all patients have been in the study for 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2010
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Intervention Details:

500 mg intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328120

Locations

Japan
Research Site
Tokyo, Japan
Research Site
Nagoyata, Japan
Research Site
Chiba, Japan
Research Site
Osaka, Japan
Research Site
Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Breast Cancer Established Brands Team Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D6995C00004, 9238IL/0062
Study First Received:	May 18, 2006
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00328120 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Advanced breast cancer
Faslodex

Study placed in the following topic categories:

Estrogen Receptor Modulators
Estrogen Antagonists
Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Breast Neoplasms
Hormones
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists

Breast Neoplasms
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009