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Quality Of Life While Receiving Faslodex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643513
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.

Condition or disease
Breast Cancer

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.
Study Start Date : June 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant




Primary Outcome Measures :
  1. To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic and/or cytological proven breast cancer.
  • Patients with metastases of breast cancer ± postmenopausal primary tumor ≥12 months.
  • Positive oestrogen receptors (ER+), positive progesterone receptors (PgR+) or unknown hormonal receptors (if duration between surgery and metastasis occurring is not less 2 years) which are indirect confirmation of hormone sensitive tumor.
  • ECOG performance status of ≤ 2
  • Patient willingness to take part in the programm
  • Life expectancy of more than 6 months.
  • Patient ability to complete a questionnaire.

Exclusion Criteria:

  • Contraindications for Faslodex therapy
  • Other anticancer therapy (chemotherapy, hormonal therapy with other drugs, radiotherapy), except for radiotherapy of sites which are not only measurable or evaluable manifestation of disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643513


Locations
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Russian Federation
Research Site
?rasnodar, Russian Federation
Research Site
Astrahan, Russian Federation
Research Site
Blagoveshenk, Russian Federation
Research Site
Chita, Russian Federation
Research Site
Igevsk, Russian Federation
Research Site
Kemerovo, Russian Federation
Research Site
Kursk, Russian Federation
Research Site
Magadan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Obninsk, Russian Federation
Research Site
Penza, Russian Federation
Research Site
Petropavlovsk, Russian Federation
Research Site
Rostov, Russian Federation
Research Site
Salehard, Russian Federation
Research Site
Samara, Russian Federation
Research Site
Sankt-Petersburg, Russian Federation
Research Site
Shahti, Russian Federation
Research Site
Surgut, Russian Federation
Research Site
Tiva, Russian Federation
Research Site
Tomsk, Russian Federation
Research Site
Tver, Russian Federation
Research Site
Ufa, Russian Federation
Research Site
Volgodonsk, Russian Federation
Research Site
Yakutsk, Russian Federation
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca Russia, Clinical Study Information
ClinicalTrials.gov Identifier: NCT00643513    
Other Study ID Numbers: NIS-ORU-FAS-2007/1
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009
Keywords provided by AstraZeneca:
QUALITY OF LIFE
POSTMENOPAUSAL WOMEN
HORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCER
FASLODEX
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists