Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Cediranib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

AZD2171

Bijoyesh Mookerjee, MD

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.

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

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.

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

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

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.

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.

AstraZeneca

Cediranib 45 mg+Fulvestrant 250 mg

Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:

* Day 1: fulvestrant 500 mg im
* Day 15: fulvestrant 250 mg im
* Day 29, and every 28 days thereafter: fulvestrant 250 mg im
* and daily: cediranib 45 mg (administered orally)

Cediranib 45 mg

Placebo+Fulvestrant 250 mg

Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:

* Day 1: fulvestrant 500 mg im
* Day 15: fulvestrant 250 mg im
* Day 29, and every 28 days thereafter: fulvestrant 250 mg im
* and daily: placebo to match cediranib (administered orally)

Spots Global Cancer Trial Database for AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

Trial Identification

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Study Description

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