Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Phase 2
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Registration Number
- JPRN-jRCT2080220373
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Exclusion Criteria
- Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Primary Outcomes: The objective response rate will be analysed when all patients have been in the study for 6 months. Secondary Outcomes: Pharmacokinetics, time to progression, duration of response, clinical benefit rate and tolerability will be analyzed when all patients have been in the study for 6 months.
- Secondary Outcome Measures
Name Time Method