A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1 POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

F. HOFFMANN-LA ROCHE LTD.0 个研究点目标入组 12 人开始时间: 2023年12月29日最近更新: 2024年8月20日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: F. HOFFMANN-LA ROCHE LTD.
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Potential participants are eligible to be included in the study only if all of the following criteria apply:
•? Signed Informed Consent Form
•? Age = 18 years at the time of signing Informed Consent Form
•? Metastatic or locally advanced unresectable, histologically documented TNBC (absence of HER2-over-expression, ER, and PgR expression by local assessment)
•o HER2 negativity (it is recommended that labs follow American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP)
•HER2 testing guidelines, and interpret as follows) by local laboratory assessment:
•? In situ hybridization non-amplified (ratio of HER2 to CEP17 = 2.0 or single probe average HER2 gene copy number < 4 signals/cell), or
•o HER2-low-status (it is recommended that labs follow ASCO-CAP HER2 testing guidelines, and interpret as follows) by local laboratory assessment:
•? IHC 2 + and in situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), or
•? IHC 1 + (and not required, but if performed, in situ hybridization non-amplified [ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell])
•o ER and PgR negativity are defined as < 1% of cells expressing hormonal receptors via IHC analysis, with testing to be performed locally
•? Measurable disease per RECIST v1.1
•? If metastatic disease (Stage IV), measurable disease outside of the bone
•? Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that same lesion since radiation
•? No prior systemic therapy for metastatic or locally advanced unresectable TNBC
•o Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy. Participants should have recovered from the effects of radiation.
•o Prior systemic therapy for early breast cancer (resectable and non-metastatic, in the neoadjuvant and/or adjuvant setting) is permitted. If prior systemic therapy was given for early TNBC, it must have included anthracycline and taxane.
•o Prior systemic therapy for early breast cancer is permitted if treatment was completed = 12 months prior to initiation of study treatment (Cycle 1, Day 1).
•o Prior anti-PD-1 or anti-PD-L1 therapeutic antibody exposure (e.g., atezolizumab or pembrolizumab) in the neoadjuvant and/or adjuvant setting is allowable if treatment was completed = 12 months prior to initiation of study treatment (Cycle 1, Day 1).
•? Tumor PD-L1 expression as documented through central testing of a representative tumor tissue specimen.
•o An FFPE tumor specimen in a paraffin block (preferred) or at least 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report. Tumor tissue must be obtained from a biopsy performed within the 3 months prior to consent. If no tumor tissue collected within the 3 months prior to consent is available, fresh tissue may be obtained or archival tissue may be used. Bone is not an acceptable source of tumor tissue.
•o Tumor tissue should be of good quality based on total and viable tumor content and will be evaluated prospectively at a central laboratory for PD-L1 expression and must be determined to be positive, as determined using:
•? the investigational VENTANA PD-L1 (SP142) Assay (positive: at least 1% of t

排除标准

•Potential participants are excluded from the study if any of the following criteria apply:
•? Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 4 months after the final dose of RO7247669 or pembrolizumab, and 6 months after the final dose of nab-paclitaxel.
•Female participants of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
•? Poor venous access
•? Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
•GFR should be assessed by calculation through use of the CKD-EPI equation:
•CKD-EPI = 142 x (serum creatinine/A)B x 0.9938Age x (1.012 if female), where A and B are the following:
•? Female serum creatinine = 0.7 mg/dL: A = 0.7 and B = -0.241
•? Female serum creatinine > 0.7 mg/dL: A = 0.7 and B = -1.2
•? Male serum creatinine = 0.9 mg/dL: A = 0.9 and B = -0.302
•? Male serum creatinine > 0.9 mg/dL: A = 0.9 and B = -1.2
•To allow for appropriate nab-paclitaxel dosing, individualized body surface area (BSA) adjusted GFR values should be used (multiply the standardized GFR by the individual’s BSA, calculated using an appropriate formula, and divide by 1.73).
•? History of malignancy within 5 years prior to consent, except for the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
•? Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
•o Asymptomatic participants with treated CNS lesions are eligible if all of the following criteria are met:
•- Measurable disease, per RECIST v1.1, must be present outside the CNS.
•- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
•- The participant has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
•- The participant has no ongoing requirement for corticosteroids as therapy for CNS disease.
•- If the participant is receiving anti-convulsant therapy, the dose is considered stable (per the investigator’s judgment).
•- Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
•- No evidence of significant vasogenic edema.
•- There is no evidence of interim progression (per the investigator’s judgment) between completion of CNS-directed therapy and initiation of study treatment.
•- Asymptomatic participants with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy and/or surgery, with no need to repeat the screening brain scan.
•? History of leptomeningeal disease
•? Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
•Participants with indwelling catheters (e.g., PleurX®) are allowed.
•? Hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected calcium > ULN) or hypercalcemia t

研究者

发起方

F. HOFFMANN-LA ROCHE LTD.

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