Breast CancerHOT ABCNCT01265654
Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 37 sites in Czechia.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 234 participants
- Where
- 37 sitesCzechia
- Study dates
- Jan 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Czechia37 sites
Research Site
Benesov U Prahy
Research Site
Brno
Research Site
České Budějovice
Research Site
Český Krumlov
Research Site
Cheb
Research Site
Chomutov
Research Site
Fryštát
Research Site
Havlíčkův Brod
Research Site
Hradec Králové
Research Site
Jablonec nad Nisou
Research Site
Jičín
Research Site
Jihlava
Research Site
Kladno
Research Site
Kolín
Research Site
Liberec
Research Site
Most
Research Site
Náchod
Research Site
Nový Jičín
Research Site
Olomouc
Research Site
Opava
Research Site
Ostrava
Research Site
Ostrava - Fifejdy
Research Site
Ostrava - Vitkovice
Research Site
Pardubice
Research Site
Pilsen
Research Site
Písek
Research Site
Prague
Research Site
Přerov
Research Site
Prostějov
Research Site
Rakovník
Research Site
Sokolov
Research Site
Strakonice
Research Site
Šumperk
Research Site
Tábor
Research Site
Ústí nad Labem
Research Site
Zlín
Research Site
Znojmo
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- Advanced Breast Cancer, Hormonal Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients with ABC and two lines of hormonal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)
Measured: Every 3 months
Secondary outcomes (3)
Changes in values of tumor markers (CEA, CA 15.3)
Measured: Every 3 months.
Time to progression
Measured: Every 3 months
Type of hormonal treatment
Measured: Every 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ales Kminek, Study director, AstraZeneca Czech RepublicKatarina Petrakova, Principal investigator, Masaryk Memorial Cancer Institute, Brno, Czech Rep.Lubos Petruzelka, Principal investigator, General Teaching Hospital, Prague, Czech Rep.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265654
- Sponsor's protocol ID
- NIS-OCZ-FAS-2010/1
- Acronym
- HOT ABC
- Status last verified
- Nov 2011
- First submitted
- 21 Dec 2010
- Last updated
- 23 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01265654
- Acronym / sponsor ID
- HOT ABC / NIS-OCZ-FAS-2010/1
- Conditions
- Breast Cancer
- Keywords
- Advanced Breast Cancer, Hormonal Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Patients with ABC and two lines of hormonal treatment |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)
Time frame: Every 3 months
3 secondary outcomes
Changes in values of tumor markers (CEA, CA 15.3)
Time frame: Every 3 months.
Time to progression
Time frame: Every 3 months
Type of hormonal treatment
Time frame: Every 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ales Kminek study director
AstraZeneca Czech Republic
Katarina Petrakova principal investigator
Masaryk Memorial Cancer Institute, Brno, Czech Rep.
Lubos Petruzelka principal investigator
General Teaching Hospital, Prague, Czech Rep.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 37 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other) (time frame: Every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.