Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer
HOT ABC
1 other identifier
observational
234
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Shorter than P25 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 23, 2011
November 1, 2011
10 months
December 21, 2010
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)
Every 3 months
Secondary Outcomes (3)
Changes in values of tumor markers (CEA, CA 15.3)
Every 3 months.
Time to progression
Every 3 months
Type of hormonal treatment
Every 3 months.
Study Arms (1)
All patients
Patients with ABC and two lines of hormonal treatment
Eligibility Criteria
Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Benesov U Prahy, Czechia
Research Site
Brno, Czechia
Research Site
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ales Kminek
AstraZeneca Czech Republic
- PRINCIPAL INVESTIGATOR
Katarina Petrakova
Masaryk Memorial Cancer Institute, Brno, Czech Rep.
- PRINCIPAL INVESTIGATOR
Lubos Petruzelka
General Teaching Hospital, Prague, Czech Rep.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2010
First Posted
December 23, 2010
Study Start
January 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 23, 2011
Record last verified: 2011-11