Faslodex Advanced Breast Cancer Local Chinese Study

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Advanced Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327769

D6997L00004

Details and patient eligibility

About

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Enrollment: 234 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal advanced breast cancer with oestrogen receptor positive
• Progression under first-line anti-oestrogen therapy.

Exclusion criteria

• Life-threatening metastasis; contraindication to anastrozole
• >2 regimens of hormonotherapy for advanced breast cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups

1

Active Comparator group

Description:

Anastrozole

Treatment:

Drug: Anastrozole

2

Experimental group

Description:

Anastrozole + Fulvestrant

Treatment:

Drug: Anastrozole

Drug: Fulvestrant