Clinical trial NCT01265654: Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer
Official title: Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Hormonal Treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 234
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)
timeFrame: Every 3 months
Secondary outcomes:
measure: Changes in values of tumor markers (CEA, CA 15.3)
timeFrame: Every 3 months.
measure: Time to progression
timeFrame: Every 3 months
measure: Type of hormonal treatment
timeFrame: Every 3 months.
Other outcomes:
Locations:
city: Benesov u Prahy
country: Czech Republic
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Cesky Krumlov
country: Czech Republic
facility: Research Site
city: Cheb
country: Czech Republic
facility: Research Site
city: Chomutov
country: Czech Republic
facility: Research Site
city: Havlickuv Brod
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Jablonec nad Nisou
country: Czech Republic
facility: Research Site
city: Jicin
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Karvina
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Kolin
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Most
country: Czech Republic
facility: Research Site
city: Nachod
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Opava
country: Czech Republic
facility: Research Site
city: Ostrava - Fifejdy
country: Czech Republic
facility: Research Site
city: Ostrava - Vitkovice
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Pisek
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Prerov
country: Czech Republic
facility: Research Site
city: Prostejov
country: Czech Republic
facility: Research Site
city: Rakovnik
country: Czech Republic
facility: Research Site
city: Sokolov
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Sumperk
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
Study officials:
affiliation: AstraZeneca Czech Republic
name: Ales Kminek
role: STUDY_DIRECTOR
affiliation: Masaryk Memorial Cancer Institute, Brno, Czech Rep.
name: Katarina Petrakova
role: PRINCIPAL_INVESTIGATOR
affiliation: General Teaching Hospital, Prague, Czech Rep.
name: Lubos Petruzelka
role: PRINCIPAL_INVESTIGATOR
References: