Clinical trial NCT00878930: Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer
Official title: Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Fulvestrant
Faslodex
Acceptability
Compliance
Efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.

Brief summary: The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.

Detailed description: In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
* Signature of the informed consent

Exclusion Criteria:

* Any contraindication to Faslodex administration

Primary outcomes:
measure: To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population.
timeFrame: monthly
measure: To collect real life data of efficacy on the use of Faslodex in the Argentine population.
timeFrame: monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Research Site
state: Buenos Aires
city: Campana
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Moron
country: Argentina
facility: Research Site
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Research Site
state: Buenos Aires
city: San Martin
country: Argentina
facility: Research Site
state: Buenos Aires
city: Tandil
country: Argentina
facility: Research Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Research Site
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Research Site
state: La Pampa
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Rio Grande
country: Argentina
facility: Research Site
state: Tierra del Fuego
city: Cordoba
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
Study officials:
References: