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Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

NCT ID: NCT01265654

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and treatment of early and breast cancer has been made in recent years breast cancer still has a significant mortality rate. A number of treatment modalities exist for postmenopausal women with advanced breast cancer. The treatment modality is chosen based on patient and tumour characteristics. Hormonal treatment is preferred and recommended in women with hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood levels of tumor markers are widely used to assess response/progression to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change of therapy in clinical study is usually done when progression based on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last several weeks. Also when a new therapy is started spurious early rises may occur. Therefore rising levels of tumor markers during the first weeks of new hormonal therapy are not necessarily sign of progression and should not be the only guidance for treatment change. Evidence of treatment efficacy form clinical studies and treatment change is based on imaging techniques.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Advanced Breast Cancer Hormonal Treatment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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All patients

Patients with ABC and two lines of hormonal treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women with at least two finished lines of hormonal treatment for advanced breast cancer Tumor markers (CEA. CA15-3) values available at the time of onset and discontinuation of therapy Imaging methods results available at the time of onset and discontinuation of therapy

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ales Kminek

Role: STUDY_DIRECTOR

AstraZeneca Czech Republic

Katarina Petrakova

Role: PRINCIPAL_INVESTIGATOR

Masaryk Memorial Cancer Institute, Brno, Czech Rep.

Lubos Petruzelka

Role: PRINCIPAL_INVESTIGATOR

General Teaching Hospital, Prague, Czech Rep.

Locations

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Benesov U Prahy, , Czechia

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Brno, , Czechia

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Cheb, , Czechia

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Chomutov, , Czechia

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České Budějovice, , Czechia

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Český Krumlov, , Czechia

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Fryštát, , Czechia

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Havlíčkův Brod, , Czechia

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Hradec Králové, , Czechia

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Jablonec nad Nisou, , Czechia

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Jičín, , Czechia

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Jihlava, , Czechia

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Kladno, , Czechia

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Kolín, , Czechia

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Liberec, , Czechia

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Most, , Czechia

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Náchod, , Czechia

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Nový Jičín, , Czechia

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Olomouc, , Czechia

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Opava, , Czechia

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Ostrava, , Czechia

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Ostrava - Fifejdy, , Czechia

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Ostrava - Vitkovice, , Czechia

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Pardubice, , Czechia

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Pilsen, , Czechia

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Písek, , Czechia

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Prague, , Czechia

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Prostějov, , Czechia

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Přerov, , Czechia

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Rakovník, , Czechia

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Sokolov, , Czechia

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Strakonice, , Czechia

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Šumperk, , Czechia

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Tábor, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Znojmo, , Czechia

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Countries

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Czechia

Other Identifiers

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NIS-OCZ-FAS-2010/1

Identifier Type: -

Identifier Source: org_study_id