AN OPEN LABEL TICENTER PHASE 2 WINDOW OF OPPORTUNITY STUDY E NG-GANETESPIB (STA-9090) MONOTHERAPY IN WOMEN WITH PREVIOUSLY UNTREATED METASTATIC HER2 POSITIVE OR TRIPLE NEGATIVE BREAST CANCER

Synta Pharmaceuticals Corp,0 个研究点目标入组 4 人开始时间: 2012年11月22日最近更新: 2023年9月4日

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•1. FEMALE 18 YEARS OF AGE
•2. PHATHOLOGICALLY CONFIRMED DIAGNOSIS OF INVASIVE BREAST CANCER.
•IF THE DISEASE IS RESTRICTED TO A SOLITARY LESION, ITS NEOPLASTIC NATURE SHOULD BE CONFIRMED BY CYTOLOGY OR HISTOLOGY
•INFLAMMATORY BREAST CANCER (IBC) IS PERMITTED BASED ON FOLLOWING CRITERIA: O CLINICALLY EVALUABLE SKIN DISEASE (ERYTHEMA, EDEMA, PEAU D´ORANGE, OR
•ULCERATIONS), WITH UNDERLYING MASS DETECTED BY PET; AND/OR O THE PRESENCE
•OF MEASURABLE DISEASE DETECTED BY CT/MR
•3. STAGE IV DISEASE (AJCC CANCER STAGING MANUAL, 7TH EDITION, 2010)
•. STAGE IIIB DISEASE PERMITTED FOR INFLAMMATORY BREAST CANCER ONLY
•4. HER2+ PATIENTS MUST HAVE RELAPSED FOLLOWING PRIOR TRASTUZAMAB, OR OTHER APPROVED ANTI-HER2 AGENT IN THE ADJUVANT SETTING. AT LEAST SIX MONTHS MUST HAVE ELAPSED SINCE THE DISCONTINUATION OF PRIOR ADJUVANT THERAPY.
•5. DOCUMENTED HER2 AND HORMONAL RECEPTOR STATUS ACCORDING TO LOCAL LABORATORY ANALYSIS
•COHORT A: HER2+ DISEASE IN PRIMARY OR METASTATIC TUMOR TISSUE, REGARDLESS OF HORMONE RECEPTOR STATUS, DEFINED AS EITHER:
•A. FISH POSITIVE
•B. OR +3 BY IMMUNOHISTOCHEMISTRY (IHC) ALONE
•C. OR +2 BY 1HC AND FISH POSITIVE
•. COHORT B: HER2 NEGATIVE, ER NEGATIVE, AND PR NEGATIVE IN PRIMARY OR METASTATIC TUMOR TISSUE

•1. PRIOR SYSTEMIC THERAPY IN THE 1ST LINE SETTING FOR METASTATIC BREAST CANCER-
•. NOTE: PATIENTS INTOLERANT TO L ST LINE SYSTEMIC THERAPY WITHOUT ANY EVIDENCE OF PROGRESSIVE DISEASE MAY BE CONSIDERED FOR INCLUSION ONLY AFTER CONSULTATION WITH THE SPONSOR MEDICAL MONITOR
•. NOTE: PRIOR THERAPY OF IBC PATIENTS IN THE 1ST LINE SETTING IS PERMITTED GIVEN THE RARITY OF THE DISEASE
•. NOTE: PATIENTS WITH ER+ AND/OR PR+ AND HER2+ DISEASE WHO RECEIVE ONE PRIOR HORMONAL THERAPY IN THE METASTATIC SETTING ARE ELIGIBLE; HOWEVER, AT LEAST 2 WEEKS MUST HAVE ELAPSED SINCE THE LAST DOSE OF HORMONAL TREATMENT
•2. DE NOVO DIAGNOSED PATIENTS WITH HER2+ DISEASE
•3. PRESENCE OF ACTIVE OR UNTREATED CNS METASTASES AS DETERMINED BY MRI/ CT SCAN PERFORMED DURING SCREENING. NOTE: PATIENTS WITH STABLE CNS METASTASES ARE ELIGIBLE
•4. ACTIVE MALIGNANCIES OTHER THAN MBC WITHIN THE LAST 5 YEARS EXCEPT ADEQUATELY TREATED IN SITU CARCINOMA OF THE CERVIX UTERI, OR BASAL OR SQUAMOUS CELL CARCINOMA OF THE SKIN.
•5. BONE AS THE ONLY SITE OF METASTATIC DISEASE FROM BREAST CANCER
•6. PROPHYLACTIC USE OF SUPPORTIVE THERAPY FOR SKELETAL RELATED EVENTS IN PATIENTS WITHOUT BONE DISEASE IS NOT PERMITTED. NOTE: SUPPORTIVE THERAPY FOR SKELETAL RELATED EVENTS (E.G., BISPHOSPHONATE, PAMIDRONATE, OR DENOSUMAB) IS ALLOWED; HOWEVER, TREATMENT MUST BE INITIATED PRIOR TO, OR WITHIN 7 DAYS AFTER, THE FIRST DOSE OF GANETESPIB

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