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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

Tracking Information
First Submitted Date March 20, 2008
First Posted Date March 26, 2008
Last Update Posted Date April 22, 2009
Study Start Date June 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 20, 2008)
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality Of Life While Receiving Faslodex
Official Title Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.
Brief Summary To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March 20, 2008)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2009
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT00643513
Other Study ID Numbers NIS-ORU-FAS-2007/1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca Russia, Clinical Study Information
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date April 2009