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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 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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220373
Enrollment
Unknown
Registered
2007-04-10
Start date
2007-04-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer, Metastatic Breast Cancer

Interventions

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026