Phase 2
N=35
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Endometrial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00334295 ↗Enrolled (actual)
35
Serious AEs
—
Results posted
Jul 2012
Primary outcome: Primary: Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fulvestrant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant |
5 | — |
| SECONDARY Time to Progression of Disease (TTP-Time To Progression, for ITT Set) |
3.1 | — |
| SECONDARY Determination (for ITT Set): Median Survival |
16.7 | — |
| SECONDARY Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities |
169 | — |
| SECONDARY Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits) |
6.0 | — |
Summary
The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, recurrent or metastatic endometrial carcinoma
- Postmenopausal
- Hormonreceptor positive
Exclusion Criteria
- Pre-treatment with Fulvestrant
- Previous endocrine therapy of the endometrial carcinoma
- Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin
Data sourced from ClinicalTrials.gov (NCT00334295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.