Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy (FACT)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastrozole; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00256698

9238SW/0001

D6997L00002

FACT

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Enrollment: 514 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion criteria

• Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
• Premenopausal women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

1

Active Comparator group

Description:

Anastrozole

Treatment:

Drug: Anastrozole

2

Experimental group

Description:

Anastrozole + Fulvestrant

Treatment:

Drug: Fulvestrant

Drug: Anastrozole