None listed
Conditions
Interventions
PATIENTS WILL BE ASSESSED FOR ELIGIBILITY FOR THE STUDY BASED ON LOCAL LABORATORY RESULTS FOR HORMONE RECEPTOR STATUS.
APPROXIMATELY 450 WOMEN WILL BE RANDOMISED 1:1 (FULVESTRANT: ANASTROZOLE). PAT
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
Female
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PROVISION OF SIGNED, WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY SPECIFIC PROCEDURES. 2. HISTOLOGICAL CONFIRMATION OF BREAST CANCER. 3. POSITIVE HORMONE RECEPTOR STATUS (ER +VE AND/OR PGR +VE) OF PRIMARY OR METASTATIC TUMOUR TISSUE BASED ON LOCAL LABORATORY ASSESSMENT. 4. HAVE EITHER . LOCALLY ADVANCED DISEASE NOT AMENABLE TO SURGERY OR RADIOTHERAPY OF CURATIVE INTENT. PATIENTS MAY HAVE HAD ONE LINE OF CYTOTOXIC CHEMOTHERAPY, FOLLOWING WHICH THEY MUST REMAIN UNSUITABLE FOR THERAPY OF CURATIVE INTENT. OR . METASTATIC DISEASE PATIENTS MAY HAVE RECEIVED ONE LINE OF CYTOTOXIC CHEMOTHERAPY AS PREVIOUS TREATMENT OF BREAST CANCER BUT MUST SHOW PROGRESSIVE DISEASE PRIOR TO ENROLMENT. 5. AT LEAST 1 LESION (MEASURABLE AND/OR NON-MEASURABLE) THAT CAN BE ACCURATELY ASSESSED AT BASELINE AND IS SUITABLE FOR REPEATED ASSESSMENT BY CT, MRI OR PLAIN X-RAY. 6. POSTMENOPAUSAL WOMAN, DEFINED AS A WOMAN FULFILLING ANY 1 OF THE FOLLOWING CRITERIA (BASED ON THE NCCN DEFINITION OF MENOPAUSE [NATIONAL COMPREHENSIVE CANCER NETWORK 2008]):
Exclusion criteria
Exclusion criteria: 1. PRESENCE OF LIFE-THREATENING METASTATIC VISCERAL DISEASE, DEFINED AS EXTENSIVE HEPATIC INVOLVEMENT, OR ANY DEGREE OF BRAIN OR LEPTOMENINGEA] INVOLVEMENT (PAST OR PRESENT), OR SYMPTOMATIC PULMONARY LYMPHANGITIC SPREAD. PATIENTS WITH DISCRETE PULMONARY PARENCHYMAL METASTASES ARE ELIGIBLE, PROVIDED THEIR RESPIRATORY FUNCTION IS NOT SIGNIFICANTLY COMPROMISED AS A RESULT OF DISEASE IN THE OPINION OF THE INVESTIGATOR. 2. PRIOR SYSTEMIC THERAPY FOR BREAST CANCER OTHER THAN ONE LINE OF CYTOTOXIC CHEMOTHERAPY (THE LAST DOSE OF CHEMOTHERAPY MUST HAVE BEEN RECEIVED MORE THAN 28 DAYS PRIOR TO RANDOMISATION). 3. RADIATION THERAPY IF NOT COMPLETED WITHIN 28 DAYS PRIOR TO RANDOMISATION (WITH THE EXCEPTION OF RADIOTHERAPY GIVEN FOR CONTROL OF BONE PAIN, WHICH MUST BE COMPLETED PRIOR TO THE DAY OF RANDOMISATION, SEE SECTION 5.6). 4. HERCEPTIN-ELIGIBLE (HER2 OVEREXPRESSION OR GENE AMPLIFICATION, IE, IMMUNOHISTOCHEMISTRY (IHC)3+VE OR FLUORESCENCE IN SITU HYBRIDISATION (FISH)+VE, WHERE APPROPRIATE). 5. PRIOR TREATMENT WITH A NON-APPROVED OR EXPERIMENTAL DRUG FOR BREAST CANCER. 6. CONCOMITANT ANTICANCER TREATMENT (WITH THE EXCEPTION OF BISPHOSPHONATES, SEE SECTION 5.6). 7. PRIOR HORMONAL TREATMENT FOR BREAST CANCER. 8. PRIOR TREATMENT WITH SYSTEMIC HORMONE REPLACEMENT THERAPY.
Countries
Argentina, Brazil, Canada, Czech Republic, India, Italy, Japan, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactAngela Flores
IQVIA RDS Peru S.R.L
Outcome results
None listed