Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer (HOT ABC)

November 22, 2011 updated by: AstraZeneca
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • 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, Czech Republic
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
All patients
Patients with ABC and two lines of hormonal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Every 3 months
Every 3 months
Changes in values of tumor markers (CEA, CA 15.3)
Time Frame: Every 3 months.
Every 3 months.
Type of hormonal treatment
Time Frame: Every 3 months.
Every 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OCZ-FAS-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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