Clinical trial NCT00357110: Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
Official title: A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast neoplasms
breast cancer
early breast cancer
oncology
cancer
breast cancer micrometastasis
fulvestrant
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
timeFrame: 12 month period following randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: St. Veit
country: Austria
facility: Research Site
city: Wiener Neustadt
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Hamburg-Eppendorf
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Porsgrunn
country: Norway
facility: Research SIte
city: Stavanger
country: Norway
facility: Research Site
city: Tonsberg
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Breast Cancer Established Brands Team Medical Science Director, MD
role: STUDY_DIRECTOR
References: