Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

AstraZeneca13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

FulvestrantDRUG

intramuscular injection

AnastrozoleDRUG

1 mg oral tablet

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (25)

Research Site

Feldkirch, Austria

Research Site

Graz, Austria

Outcomes

Primary Outcomes

Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)

Number of patients event-free

Time frame: 12 month period following randomisation

Data from ClinicalTrials.gov

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