Endometrial Carcinoma
Conditions
Keywords
Recurrent or metastatic endometrial carcinoma
Brief 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.
Interventions
DRUGFulvestrant
A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 1 year | Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression of Disease (TTP-Time To Progression, for ITT Set) | ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression) | median TTP |
| Determination (for ITT Set): Median Survival | ICF to the date of death | median overall survival (OS) |
| Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities | ICF to Last Patient Out (LPO) | number of adverse events |
| Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits) | ICF (Baseline) up to 12 months (12 visits) | Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fulvestrant A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients received fewer than 3 injection | 5 |
Baseline characteristics
| Characteristic | Fulvestrant |
|---|---|
| Age, Customized | 69.5 years |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / — |
| serious Total, serious adverse events | 11 / — |
Outcome results
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
Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.
Time frame: up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fulvestrant | 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 |
Secondary
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities
number of adverse events
Time frame: ICF to Last Patient Out (LPO)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fulvestrant | Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities | 169 adverse events |
Secondary
Determination (for ITT Set): Median Survival
median overall survival (OS)
Time frame: ICF to the date of death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fulvestrant | Determination (for ITT Set): Median Survival | 16.7 months |
Secondary
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)
Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).
Time frame: ICF (Baseline) up to 12 months (12 visits)
Population: FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fulvestrant | Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits) | 6.0 units on a scale |
Secondary
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
median TTP
Time frame: ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fulvestrant | Time to Progression of Disease (TTP-Time To Progression, for ITT Set) | 3.1 months |