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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00328120 |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Research Site | |
Tokyo, Japan | |
Research Site | |
Nagoyata, Japan | |
Research Site | |
Chiba, Japan | |
Research Site | |
Osaka, Japan | |
Research Site | |
Fukuoka, Japan |
Study Director: | Breast Cancer Established Brands Team Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D6995C00004, 9238IL/0062 |
Study First Received: | May 18, 2006 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00328120 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Advanced breast cancer Faslodex |
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 |
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 |