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Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy (COPA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT00814034
First received: December 22, 2008
Last updated: July 29, 2011
Last verified: July 2011
History of Changes
  Purpose

The objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5 years. The values of the standard coagulation parameters throughout the study will be compared with the baseline values.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Prospective Cohort Study, on Blood Coagulation Parameters in Postmenopausal Patients With Operable Breast Cancer Who Are Treated as Per Standard Practice With Adjuvant Hormonal Therapy for a Total of 5 Years

Resource links provided by NLM:

Drug Information available for: Tamoxifen
U.S. FDA Resources

Further study details as provided by Hellenic Breast Surgeons Society:

Primary Outcome Measures:
  • Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: February 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1:Tamoxifen
2:Steroidal Aromatase Inhibitor
3:Non-steroidal Aromatase Inhibitor

Detailed Description:

Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons. The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. The blood coagulation parameters which will be measured are fibrinogen, prothrombin time (PT) and activated partial thromboplastin time (aPTT).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal, ER and/or PgR positive breast cancer patients eligible for adjuvant hormonal treatment (HT), who are admitted for treatment and follow-up at the participating sites, will be enrolled in the trial. Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons.

The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy.

Criteria

Inclusion Criteria:

  • Postmenopausal status. ER and/or PgR status positive. Adjuvant hormonal treatment for 5 years according to standard practice has been decided by the treating physician. Values within normal limits for the blood coagulation parameters at baseline visit. Accessible for follow-up for the duration of the trial. Written informed consent.

Exclusion Criteria:

  • Both ER and PgR negative primary tumor. Evidence of distant metastases (M1) Neo-adjuvant hormonotherapy. Chronic use of oral anticoagulants such as warfarin or acenocoumarol. Psychiatric disorders preventing proper informed consent. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814034

Locations
Greece
Hellenic Breast Surgeons Society
Athens, Attica, Greece, 11523
Hellenic Breast Surgeons Society
Athens, Greece, 11527
Sponsors and Collaborators
Hellenic Breast Surgeons Society
Investigators
Principal Investigator: Christos Markopoulos, MD Hellenic Breast Surgeons Society
  More Information

No publications provided

Responsible Party: Markopoulos Christos, Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier: NCT00814034     History of Changes
Other Study ID Numbers: COPA-HBSS0801
Study First Received: December 22, 2008
Last Updated: July 29, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Breast Surgeons Society:
Aromatase Inhibitors
Coagulation parameters
Tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013