ABOUT THIS STUDY
- Pathological diagnoses of breast cancer.
- Postmenopausal women, defined as:
- Bilateral surgical oophorectomy or amenorrhoea >= 5 years;
- Age >= 56 years old and amenorrhoea >= 1 year;
- Chemotherapy induced amenorrhoea >= 2 years;
- Radiotherapy induced amenorrhoea at least 3 months before:
- Age < 56 and < 5 years of amenorrhoea: follicle-stimulating hormone (FSH) levels to confirm postmenopausal status.
- Metastatic breast cancer (stage IV) or non-operable locally advanced breast cancer (stage IIIB).
- Positive estrogen and/or progesterone receptors as >10% cells or >10fmol/mg.
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Patients who have received adjuvant tamoxifen are eligible, if progression has been established at least 24 months since treatment start.
- Neoadjuvant chemotherapy is allowed if progression has been established at least 12 months after end of treatment.
- Patients may have received a first line of chemotherapy for advanced disease, but treatment must have ended at least 4 weeks before enrolment, and all acute toxicities must be resolved. Previous treatment with Herceptin is allowed.
- Normal haematological, hepatic and renal functions.
- Performance status ECOG of 0, 1, 2.
- Life expectancy superior to 3 months.
- Written informed consent.
- Previous hormone treatment for metastatic disease.
- Previous treatment with aromatase inhibitors.
- Inflammatory breast cancer, or aggressive metastatic disease, or visceral lesions, or
metastasis in the central nervous system (CNS).
- Non-measurable disease.
- Second malignancy except for basal skin carcinoma or cervical in situ carcinoma
adequately treated. If other malignancies, patient must have a disease-free period
superior to 5 years.
- Treatment with any investigational product in the 4 previous weeks.
- Patients with negative estrogen and progesterone receptor tumours.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Washington, District of Columbia
- Baltimore, Maryland
- Badalona, Barcelona