A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTRE, PHASE III STUDY TO COMPARE THE EFFICACY AND TOLERABILITY OF FULVESTRANT (FASLODEX TM) 500 MG WITH ANASTROZOLE (ARIMIDEX TM) 1 MG AS HORMONAL TREATMENT FOR POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE NOT PREVIOUSLY BEEN TREATED WITH ANY HORMONAL THERAPY (FALCON)
- Registration Number
- PER-090-12
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 33
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]):
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method