A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PAHSE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF TKI258 COMBINED WITH FULVESTRANT, IN POSTMENOPAUSAL PATIENTS WITH HER-2 AND HR+ BREAST CANCER THAT HAVE EVIDENCE OF DISEASE PROGRESSION ON OR AFTER PRIOR ENDOCRINE THERAPY

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2012年10月9日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. WRITTEN INFORMED CONSENT OBTAINED PRIOR TO ANY STUDY PROCEDURES, INCLUDING SCREENING ASSESSMENTS
•2. POSTMENOPAUSAL (≥ 18 YEARS) WOMEN WITH HER2-, HR+ (ER+ AND/OR PGR+), LOCALLY ADVANCED OR METASTATIC BREAST CANCER NOT AMENABLE TO CURATIVE TREATMENT BY SURGERY OR RADIOTHERAPY. POSTMENOPAUSAL STATUS IS DEFINED EITHER BY:
•. AGE ≥ 55 YEARS AND ONE YEAR OR MORE OF AMENORRHEA, OR
•. AGE < 55 YEARS AND ONE YEAR OR MORE OF AMENORRHEA IN THE ABSENCE OF OVARIAN SUPPRESSION, WITH AN ESTRADIOL ASSAY < 20 PG/ML, OR
•. SURGICAL MENOPAUSE WITH BILATERAL OOPHORECTOMY. NOTE THAT IT IS NOT POSSIBLE TO ASSIGN MENOPAUSE STATUS TO WOMEN WHO ARE RECEIVING AN LH-RH AGONIST OR ANTAGONIST.
•3. BREAST CANCER THAT HAS PROGRESSED ON OR AFTER PRIOR ENDOCRINE THERAPY, WITH RADIOLOGICAL EVIDENCE OF RECURRENCE OR PROGRESSION AS FOLLOWS:
•. WHILE ON, OR WITHIN 12 MONTHS OF END OF ADJUVANT TREATMENT WITH ANY ENDOCRINE THERAPY (E.G., TAMOXIFEN, EXEMESTANE, ANASTROZOLE, LETROZOLE, ETC.)
•. WHILE ON, OR WITHIN 1 MONTH OF END OF ANY ENDOCRINE THERAPY TREATMENT FOR LA/MBC

•1. EVIDENCE OF CENTRAL NERVOUS SYSTEM (CNS) OR LEPTOMENINGEA] METASTASES. A BRAIN CT SCAN OR MR´ IS MANDATORY AT SCREENING PRIOR TO STUDY ENTRY
•2. HER2 OVER EXPRESSION AS DEPICTED BY LOCAL LABORATORY IHC 3+ OR FISH TESTING.
•3. PREVIOUSLY TREATED WITH FULVESTRANT AS A SINGLE AGENT OR IN COMBINATION WITH OTHER THERAPIES OR FGFR INHIBITORS
•4. HAVE ANY CONTRAINDICATION FOR BEING TREATED WITH FULVESTRANT 500 MG AS DESCRIBED IN THE LOCAL APPROVED PRESCRIBING INFORMATION
•5. RECEIVED MORE THAN ONE LINE OF ANY PRIOR HORMONAL THERAPY FOR LA/MBC. ANY ADJUVANT/NEO ADJUVANT THERAPY IS ALLOWED
•6. RECEIVED ANY CHEMOTHERAPY FOR LA/MBC
•7. CONCURRENT USE OF ANY OTHER APPROVED OR INVESTIGATIONAL ANTICANCER AGENTS, INCLUDING HORMONAL AGENTS
•8. HAVING PARTICIPATED IN A PRIOR INVESTIGATIONAL STUDY WITHIN 30 DAYS PRIOR TO ENROLLMENT OR ≥ 5 HALF-LIVES OF THE INVESTIGATIONAL PRODUCT, WHICHEVER IS LONGER
•9. RECEIVED THE LAST ADMINISTRATION OF ANTI-CANCER TARGETED SMALL MOLECULE THERAPY (E.G. SUNITINIB, SORAFENIB, PAZOPANIB, AXITINIB, EVEROLIMUS, TEMSIROLIMUS, RADAFOROLIMUS) < 2 WEEKS PRIOR TO STARTING STUDY DRUG, OR WHO HAVE NOT RECOVERED FROM THE SIDE EFFECTS OF SUCH THERAPY

发起方

OVARTIS BIOSCIENSES PERU S.A.,