Clinical trial NCT00623519: Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
Official title: Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Adjuvant postmenopausal breast cancer women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Oncology

Brief summary: To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.


Eligibility 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

Primary outcomes:
measure: Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
timeFrame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.
Secondary outcomes:
measure: To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
timeFrame: During the study, at least annually
measure: Histological assessment when indicated(type of hyperplasia)
timeFrame: When applicable
measure: To assess global incidence of endometrial changes in this patient population before taking Anastrozole
timeFrame: During the study
measure: To evaluate type of surgery required for endometrial changes control(hysterectomy rate)
timeFrame: During the study
measure: To assess treatment tolerability
timeFrame: During the study
Other outcomes:
Locations:
city: Coruña
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Ibiza
country: Spain
facility: Research Site
city: Jerez
country: Spain
facility: Research Site
city: La Rioja
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Mallorca
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca Spain
name: Rosana Cajal, MD
role: STUDY_DIRECTOR
References: