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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

The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

AZD2171 in Addition to Fulvestrant in Patients with Advanced Breast Cancer.

Research Site

A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination with Fulvestrant vs Fulvestrant alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients

Age Continuous

Gender, Male/Female

Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Progression Free Survival

Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease.  Best objective tumour response defined as:
Complete Response (CR)	Disappearance of all target lesions
Partial response (PR)	At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Progression (PD)	At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.  
Stable disease (SD)	Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Objective Response Rate

Number of days from date of response (complete/partial based on RECIST) to date of progression

Duration of Response

Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.
The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off.

Clinical Benefit Rate

Number of days from date of clinical benefit to date of progression.
Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.

Duration of Clinical Benefit

Overall Study

In this study, 75 patients were enrolled and 62 randomised.

Arms	Assigned Interventions
Active Comparator: 2 Fulvestrant Monotherapy	Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 3 AZD2171 + Fulvestrant	Drug: AZD2171 Oral tablet Other Name: Recentin Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238

AZD2171 in Addition to Fulvestrant in Patients with Advanced Breast Cancer.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR-D8480C00007.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator