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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Fulvestrant 250 mg (intramuscular injection 250 mg)

Fulvestrant 250 mg (+ 250 mg loading regimen)

Fulvestrant 500 mg (intramuscular injection 500 mg)

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

A clinical trial to compare efficacy and tolerability of Fulvestrant 250mg, 250mg plus 250mg Loading regimen and 500mg

NCT ID

Patient Level Data

Therapeutic Area

AstraZeneca Clinical Trial Information – Outside US

Cancer Study Locator (US and Canada only)

Research Site

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

Number of participants who were objective responders over the number  of participants evaluable for response x100.  An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).

Objective Response (ORR)

Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.

Time to Progression (TTP)

DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.

Duration of Response (DoR)

CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks.

Clinical Benefit Rate (CBR)

A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.

Pharmacokinetic Parameter: Mean population clearance, a measure of the efficiency with which Fulvestrant is eliminated from the body

V1/F

V2/F

A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.

Pharmacokinetic Parameter: Mean volume of distribution at steady state, a measure of the apparent volume in the body into which Fulvestrant distributes

Overall Study

Gerard Lynch

Median time (in days) from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method

DoR was defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression or death from any cause.

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD, provided that the SD was present at least 154 days from randomisation (ie. SD>=24 weeks - with the 2 week RECIST assessment time window allowed).  The Clinical Benefit Rate is the percentage of patients with CB.

The measure of dispersion for mean population clearance is based on the estimated inter-individual variance.

The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes

Arms	Assigned Interventions
Experimental: 1 Fulvestrant 250 mg (intramuscular injection 250 mg)	Drug: Fulvestrant intramuscular injection 250 mg & 500 mg Other Name: Faslodex Other Name: ZD9238
Experimental: 2 Fulvestrant 250 mg (+ 250 mg loading regimen)	Drug: Fulvestrant intramuscular injection 250 mg & 500 mg Other Name: Faslodex Other Name: ZD9238
Experimental: 3 Fulvestrant 500 mg (intramuscular injection 500 mg)	Drug: Fulvestrant intramuscular injection 250 mg & 500 mg Other Name: Faslodex Other Name: ZD9238

A clinical trial to compare efficacy and tolerability of Fulvestrant 250mg, 250mg plus 250mg Loading regimen and 500mg - FINDER II

Official Title

Medical condition

Phase

Healthy volunteers

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

AstraZeneca Clinical Trial Information – Outside US

Cancer Study Locator (US and Canada only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=407&filename=CSR-D6997C00006.pdf

CSR-D6997C00006.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator