NL-OMON51786招募中3 期
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician*s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1. - ASCENT-03
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for
- •participation in this study (no waivers for patient eligibility will be offered
- •or permitted):
- •1) Female or male patients, regardless of race and ethnic group, who are 18
- •years of age or older, able to understand and give written informed consent.
- •2) Patients with locally advanced, inoperable, or metastatic TNBC who have not
- •received previous systemic therapy for advanced disease and whose tumors are
- •PD-L1 negative at screening. Alternatively, patients whose tumors are PD-L1
- •positive at screening will be eligible if they received an anti-programmed
- •death (ligand) 1 (anti-PD-[L]1) agent (ie, checkpoint inhibitor) in the
- •adjuvant or neoadjuvant setting or if they cannot be treated with an
- •anti-PD-(L)1 agent due to a comorbidity.
- •a) Patients must have completed treatment for Stage I-III breast cancer, if
- •indicated, and >= 6 months must have elapsed between completion of treatment
- •with curative intent (eg, date of primary breast cancer surgery or date of last
- •(neo)adjuvant chemotherapy administration [including anti-PD-(L)1 treatment],
- •whichever occurred last) and first
- •documented local or distant disease recurrence. Dates of postoperative
- •radiotherapy are not included in this calculation.
- •i) Patients who received taxane, gemcitabine, or platinum agents in the
- •(neo)adjuvant setting can be treated with same class of chemotherapy (taxane or
- •gemcitabine/carboplatin) if >= 12 months have elapsed between the completion of
- •treatment with curative intent (eg, date of primary breast tumor surgery or
- •date of last (neo)adjuvant chemotherapy administration, whichever occurred
- •last) and first documented local or distant disease recurrence.
- •ii) Patients enrolled should have received prior anthracycline in the
- •(neo)adjuvant setting or be considered not eligible for anthracyclines as
- •assessed by the treating physician.
- •b) Patients presenting with de novo metastatic TNBC are eligible for this study.
- •c) TNBC status and tumor PD-L1 CPS will be confirmed centrally on a recent or
- •archival tumor specimen. Patients must have histologically or cytologically
- •documented TNBC, according to current ASCO/CAP criteria, defined as negative
- •for ER, progesterone receptor, and HER2. Patients initially diagnosed with
- •hormone receptor-positive or HER2-positive breast cancer must have central
- •confirmation of TNBC in a tumor biopsy obtained from a local recurrence or
- •distant metastasis prior to entry. Tumor combined positive score (CPS) < 10
- •using the PD-L1 IHC 22C3 assay will be required for eligibility. Alternatively,
- •patients with tumor CPS >= 10 will be eligible if they received an
- •anti--PD--(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant
- •setting or if they cannot be treated with an antiPD-(L)1 agent due to a
- •comorbidity.
- •d) Patients must have measurable disease by CT or MRI as per RECIST Version 1.1
- •criteria as evaluated locally. Tumor lesions situated in a previously
- •irradiated area are considered measurable if unequivocal progression has been
- •documented in such lesions since radiation.
- •3) Have provided representative formalin-fixed paraffin-embedded (FFPE) tumor
- •specimen in blocks (preferred) or have at least 20 to 25 freshly sectioned
- •unstained slides from fresh biopsy tissue (preferred) or
排除标准
- •Patients who meet any of the following exclusion criteria are not eligible to
- •be enrolled in this study (no waivers for patient eligibility will be offered
- •or permitted):
- •1) Positive serum pregnancy test or women who are lactating.
- •2) Known or severe (>= Grade 3) hypersensitivity or allergy to sacituzumab
- •govitecan and/or the chemotherapy regimen of choice in the TPC arm (eg,
- •nab-paclitaxel, paclitaxel, gemcitabine, or Carboplatin), their metabolites, or
- •formulation excipient.
- •3) Requirement for ongoing therapy with or prior use of any prohibited
- •medications listed in section 5.6.1 of the protocol.
- •4) Patients may not have received systemic anticancer treatment (with the
- •exception of endocrine therapy) within the previous 6 months or radiation
- •therapy within 2 weeks prior to enrollment. Patients must have recovered (ie, >
- •Grade 2 is considered not recovered) from AEs due to a previously administered
- •agent at the time of study entry.
- •- Note: patients with any grade neuropathy or alopecia are an exception to this
- •criterion and will qualify for the study.
- •- Note: if patients received major surgery, they must have recovered adequately
- •from the toxicity and/or complications from the intervention prior to starting
- •5) Patients may not be participating in a study with an investigational agent
- •or investigational device within 4 weeks prior to randomization. Patients
- •participating in observational studies are eligible.
- •6) Have previously received topoisomerase 1 inhibitors or antibody drug
- •conjugates containing a topoisomerase inhibitor.
- •7) Have an active second malignancy.
- •8) Have known active central nervous system (CNS) metastases and/or
- •carcinomatous meningitis. Patients with previously treated brain metastases may
- •participate (with the exception of those treated with chemotherapy) provided
- •they have stable CNS disease (defined as radiographic stability demonstrated
- •with a minimum of 2 posttreatment brain imaging assessments; one performed
- •during screening) for at least 4 weeks prior to enrollment and all neurologic
- •symptoms have returned to baseline, have no evidence of new or enlarging brain
- •metastases, and have also been clinically stable for at least 2 weeks while
- •taking <= 10 mg/day of prednisone or its equivalent. All patients with
- •carcinomatous meningitis are excluded regardless of clinical stability.
- •9) Met any of the following criteria for cardiac disease:
- •a) Myocardial infarction or unstable angina pectoris within 6 months of
- •enrollment.
- •b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or
- •ventricular fibrillation), high-grade atrioventricular block, or other cardiac
- •arrhythmias requiring antiarrhythmic medications (except for atrial
- •fibrillation that is well controlled with antiarrhythmic medication); history
- •of QT interval prolongation.
- •c) New York Heart Association Class III or greater congestive heart failure or
- •known left ventricular ejection fraction of < 40%.
- •10) Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn*s
- •disease) or GI perforation within 6 months of enrollment.
- •11) Have active serious infection requiring antibiotics.
- •12) Patients positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
- •Multicentric Castleman Disease.
- 另有 1 项未显示
研究者
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