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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

AZD8931 40mg (bd) plus anastrozole 1mg (od)

AZD8931 20mg (bd) plus anastrozole 1mg (od)

The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.

Study of Anastrozole +/- AZD8931 in Postmenopausal Women with Endocrine Therapy Naive Breast Cancer

Research Site

A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination with Anastrozole, Compared to Anastrozole alone, in Post menopausal Women With Hormone Receptor positive, Endocrine Therapy naive, Locally advanced or Metastatic Breast Cancer (MINT).

Age Continuous

Gender, Customized

Ethnicity

Race/Ethnicity, Customized

Study was stratified by locally advanced / metastatic disease

Study Stratification: Disease Classification

Study Specific Characteristic

Race

The final analysis for this study is the analysis that was sent to the study's IDMC, based on a data cut-off of 31 August 2012. At the data cut-off point the data was cleaned, but 9 adverse events were not coded. These events are not included here.

Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)

345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.

345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.

Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to. 

Progression free survival as evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Time from the date of randomization to the date of death (by any cause)

Compare the overall survival in patients treated with AZD8931 in combination with anastrozole versus anastrozole alone

Overall Study

Dr Serban Ghiorghiu

Not limited to phosphorylated and total erbB1, erbB2 and erbB3, truncated (p95) Her2, pER, PTEN, AKT, ERK, erbB receptor dimers (hetero- and homo-dimers), and ligands for the erbB receptor family (EGF, TGF-alpha, amphiregulin, betacellulin, HB-EGF, epiregulin, NRG1, 2,3,4) by comparison of pre-treatment versus on-treatment or at progression levels following therapy with AZD8931 or matching placebo.For all exploratory objectives, AstraZeneca are committed to perform laboratory analysis on all or a proportion of these biomarkers, dependent on sample size and tissue quality.

For all exploratory objectives, AstraZeneca are committed to perform laboratory analysis on all or a proportion of these biomarkers, dependent on sample size and tissue quality.

Into factors that may influence development of cancer and/or response to AZD8931(where response is defined broadly to include efficacy or tolerability).
                    
                    For all exploratory objectives, AstraZeneca are committed to perform laboratory analysis on all or a proportion of these biomarkers, dependent on sample size and tissue quality.

Arms	Assigned Interventions
Experimental: 1 AZD8931 40mg (bd) plus anastrozole 1mg (od)	Drug: AZD8931 Tablet, oral, bd Drug: anastrozole Tablet, oral, od Other Name: Arimidex
Experimental: 2 AZD8931 20mg (bd) plus anastrozole 1mg (od)	Drug: AZD8931 Tablet, oral, bd Drug: anastrozole Tablet, oral, od Other Name: Arimidex
Placebo Comparator: 3 Placebo (bd) plus anastrozole 1mg (od)	Drug: anastrozole Tablet, oral, od Other Name: Arimidex Drug: Placebo Tablet, oral

Study of Anastrozole +/- AZD8931 in Postmenopausal Women with Endocrine Therapy Naive Breast Cancer - MINT

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

D0102C00004 Study Synopsis report

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator