|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00623519 |
|
Date of registration:
|
06/02/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
|
|
Scientific title:
|
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole. |
|
Date of first enrolment:
|
June 2004 |
|
Target sample size:
|
165 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00623519 |
|
Study type:
|
Observational |
|
Study design:
|
Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Rosana Cajal, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca Spain |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Provision of Informed Consent
- Resectable breast cancer patients, with histological confirmation
- Patients eligible to receive hormonal adjuvant treatment with Anastrozole
- They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
- Patients previously treated with Tamoxifen that had to withdraw treatment due to
other reason than endometrial changes are allowed
- Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH
level >40UI/L / women under 50 years with FSH levels>40UI/L).
- Women showing progesterone and/or estrogen receptors positive.
Exclusion Criteria:
- Patients with evidence of metastatic disease
- Patients unsuitable to receive the medication according the Anastrozole label
- Patients not giving their Informed Consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Primary Outcome(s)
|
|
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
[Time Frame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.]
|
|
Secondary Outcome(s)
|
|
To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
[Time Frame: During the study, at least annually]
|
|
Histological assessment when indicated(type of hyperplasia)
[Time Frame: When applicable]
|
|
To assess global incidence of endometrial changes in this patient population before taking Anastrozole
[Time Frame: During the study]
|
|
To evaluate type of surgery required for endometrial changes control(hysterectomy rate)
[Time Frame: During the study]
|
|
To assess treatment tolerability
[Time Frame: During the study]
|
|
Secondary ID(s)
|
|
AST-ANA-2004-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|