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

AstraZeneca75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Advanced Breast Cancer

Interventions

AZD2171DRUG

Oral tablet

FulvestrantDRUG

intramuscular injection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease * One or more evaluable lesions Exclusion Criteria: * Prior hormonal therapy with fulvestrant * More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer * Prior biologic therapy for ABC including Anti-VEGF agents * Radiation therapy within 4 weeks prior to provision of consent

Locations (16)

Research Site

Burbank, California, United States

Research Site

Los Angeles, California, United States

Research Site

Palm Springs, California, United States

Outcomes

Primary Outcomes

Progression Free Survival

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.

Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Secondary Outcomes

Objective Response Rate

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

Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Duration of Response

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

Time frame: Every 8 weeks until progression or discontinuation

Clinical Benefit Rate

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.

Data from ClinicalTrials.gov

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