Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer (HOT ABC)
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Purpose
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.
| Condition |
|---|
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Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer |
- Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Changes in values of tumor markers (CEA, CA 15.3) [ Time Frame: Every 3 months. ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Type of hormonal treatment [ Time Frame: Every 3 months. ] [ Designated as safety issue: No ]
| Enrollment: | 234 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All patients
Patients with ABC and two lines of hormonal treatment
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.
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
Contacts and Locations| Czech Republic | |
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| Benesov u Prahy, Czech Republic | |
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| Brno, Czech Republic | |
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| Ceske Budejovice, Czech Republic | |
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| Cesky Krumlov, Czech Republic | |
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| Cheb, Czech Republic | |
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| Chomutov, Czech Republic | |
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| Havlickuv Brod, Czech Republic | |
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| Hradec Kralove, Czech Republic | |
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| Jablonec nad Nisou, Czech Republic | |
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| Jicin, Czech Republic | |
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| Jihlava, Czech Republic | |
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| Karvina, Czech Republic | |
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| Kladno, Czech Republic | |
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| Kolin, Czech Republic | |
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| Liberec, Czech Republic | |
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| Most, Czech Republic | |
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| Nachod, Czech Republic | |
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| Novy Jicin, Czech Republic | |
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| Olomouc, Czech Republic | |
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| Opava, Czech Republic | |
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| Ostrava, Czech Republic | |
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| Ostrava - Fifejdy, Czech Republic | |
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| Ostrava - Vitkovice, Czech Republic | |
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| Pardubice, Czech Republic | |
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| Pisek, Czech Republic | |
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| Plzen, Czech Republic | |
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| Praha, Czech Republic | |
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| Prerov, Czech Republic | |
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| Prostejov, Czech Republic | |
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| Rakovnik, Czech Republic | |
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| Sokolov, Czech Republic | |
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| Strakonice, Czech Republic | |
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| Sumperk, Czech Republic | |
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| Tabor, Czech Republic | |
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| Usti nad Labem, Czech Republic | |
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| Zlin, Czech Republic | |
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| Znojmo, Czech Republic | |
| 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. |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01265654 History of Changes |
| Other Study ID Numbers: | NIS-OCZ-FAS-2010/1 |
| Study First Received: | December 21, 2010 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by AstraZeneca:
|
Advanced Breast Cancer Hormonal Treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013