Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

Breast Cancer Clinical Trial

— HOT ABC  

Official title:

Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265654
• Other study ID #: NIS-OCZ-FAS-2010/1
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: November 22, 2011
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Czech Republic	Research Site	Benesov u Prahy
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Cesky Krumlov
Czech Republic	Research Site	Cheb
Czech Republic	Research Site	Chomutov
Czech Republic	Research Site	Havlickuv Brod
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Jablonec nad Nisou
Czech Republic	Research Site	Jicin
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Karvina
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Kolin
Czech Republic	Research Site	Liberec
Czech Republic	Research Site	Most
Czech Republic	Research Site	Nachod
Czech Republic	Research Site	Novy Jicin
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Opava
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Ostrava - Fifejdy
Czech Republic	Research Site	Ostrava - Vitkovice
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Pisek
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Prerov
Czech Republic	Research Site	Prostejov
Czech Republic	Research Site	Rakovnik
Czech Republic	Research Site	Sokolov
Czech Republic	Research Site	Strakonice
Czech Republic	Research Site	Sumperk
Czech Republic	Research Site	Tabor
Czech Republic	Research Site	Usti nad Labem
Czech Republic	Research Site	Zlin
Czech Republic	Research Site	Znojmo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)		Every 3 months	No
Secondary	Changes in values of tumor markers (CEA, CA 15.3)		Every 3 months.	No
Secondary	Time to progression		Every 3 months	No
Secondary	Type of hormonal treatment		Every 3 months.	No