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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01265654
First received: December 21, 2010
Last updated: November 22, 2011
Last verified: November 2011
  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
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Postmenopausal women with hormone sensitive advanced breast cancer that have been treated with minimum two hormonal agents according to approved SmPC.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265654

Locations
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, Czech Republic
Sponsors and Collaborators
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.
  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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014