Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer (@FAME)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357110

D6990C00001

Eudract No 2005-005715-22

ABCSG21

Details and patient eligibility

About

Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Enrollment: 13 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation

Exclusion criteria

• Inflammatory and/or metastatic breast cancer.
• Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
• History of bleeding diathesis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

1

Active Comparator group

Description:

Anastrozole monotherapy

Treatment:

Drug: Anastrozole

2

Experimental group

Description:

Anastrozole + Fulvestrant

Treatment:

Drug: Anastrozole

Drug: Fulvestrant