Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Anastrazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259090

9238IL/0057

D6997C00057

Details and patient eligibility

About

To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.

Enrollment: 120 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women.
• Biopsy confirmation of primary breast cancer.
• Oestrogen receptor positive tumour.
• Fit for surgery within one month.
• Written informed consent to participate in the study

Exclusion criteria

• Previous treatment with any anti-hormonal therapy for breast cancer.
• Previous radiotherapy to the primary tumour.
• Previous chemotherapy for the primary tumour.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

1

Active Comparator group

Description:

Anastrozole Monotherapy

Treatment:

Drug: Anastrazole

2

Experimental group

Description:

Fulvestrant Monotherapy

Treatment:

Drug: Fulvestrant

3

Experimental group

Description:

Anastrozole + Fulvestrant

Treatment:

Drug: Anastrazole

Drug: Fulvestrant