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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Drug: AZD2171; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454805

D8480C00007

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

2

Active Comparator group

Description:

Fulvestrant Monotherapy

Treatment:

Drug: Fulvestrant

3

Experimental group

Description:

AZD2171 + Fulvestrant

Treatment:

Drug: Fulvestrant

Drug: AZD2171