EUCTR2017-000565-76-AT进行中（未招募）1 期
SHERBOC: A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Systemic Therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •In order for inclusion, patients must have/be:
- •Histologically or cytologically confirmed ER+ and/or PR+ (with staining of > 1% cells) breast cancer
- •Confirmed postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist, such as goserelin
- •HER2 negative per ASCO/CAP guidelines
- •A positive in-situ hybridization (ISH) test for heregulin with a score of =1+, as determined by centralized testing of unstained tumor tissue
- •Must have at least one lesion amenable to either fresh tissue biopsy
- •Progressed following at least one but no more than two prior systemic therapies in the locally advanced or metastatic disease setting
- •o Received prior CDK inhibitor based therapy for locally advanced or metastatic disease
- •Documented progression of locally advanced or metastatic disease as defined by RECIST v1.1. Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lytic lesions visible on a CT or MRI and have documented disease progression on prior therapy, based on RECIST v1.1 criteria.
- •o Patients with bone-only lesions who have received radiation to those lesions must have documented progression following radiation therapy.
- •Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- •ECOG Performance Score (PS) of 0 or 1
- •Adequate bone marrow reserves as evidenced by:
- •-ANC > 1500/µl
- •-Platelet count > 100,000/µl; and
- •-Hemoglobin > 9 g/dL
- •Adequate hepatic function as evidenced by:
- •-Serum total bilirubin = 1.5 x ULN except for patients with Morbus Gilbert
- •-Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase = 2.5 x ULN (= 5 x ULN is acceptable if liver metastases are present, and = 5 x ULN of Alkaline Phosphatase is acceptable if bone metastases are present)
- •Adequate renal function as evidenced by a serum creatinine = 1.5 x ULN
- •Recovered from clinically significant effects of any prior surgery, radiotherapy, or other antineoplastic therapy.
- •Patients may be treated with bone modifying agents such as bisphosphonates or receptor activator of nuclear factor kappa-B (RANK)-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment > 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
- •= 18 years of age
- •Patients who have experienced a venous thromboembolic event within 60 days of signing the main consent form should have been treated with anti-coagulants for at least 7 days prior to beginning treatment and for the duration of treatment on this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
排除标准
- •Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria:
- •Prior treatment with an anti-ErbB3 antibody
- •Prior treatment with a chemotherapy in the locally advanced or metastatic disease setting
- •Patients cannot have received prior fulvestrant or other SERDs in the locally advanced or metastatic setting
- •Uncontrolled CNS disease or presence of leptomeningeal disease
- •Inflammatory breast cancer
- •History of another active malignancy that required systemic therapy in the last 2 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible.
- •Active infection, or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
- •Known hypersensitivity to any of the components of seribantumab, fulvestrant, or who have had hypersensitivity reactions to fully human monoclonal antibodies
- •Received other recent antitumor therapy including:
- •-Investigational therapy administered within the 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing in this study
- •-Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation
- •NYHA Class III or IV congestive heart failure
- •Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; or active human immunodeficiency virus (HIV) infection, active hepatitis B infection or active hepatitis C infection
- •Any other medical condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, interfere with a patient’s ability to cooperate and participate in the study, or interfere with the interpretation of the results
研究者
相似试验
进行中（未招募）
1 期
Study of seribantumab plus fulvestrant versus placebo plus fulvestrant in heregulin positive breast cancerEUCTR2017-000565-76-ITMerrimack Pharmaceuticals, Inc.80
进行中（未招募）
1 期
Study of seribantumab plus fulvestrant versus placebo plus fulvestrant in heregulin positive breast cancerHormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast CancerMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2017-000565-76-DEMerrimack Pharmaceuticals, Inc.80
进行中（未招募）
1 期
Study of seribantumab plus fulvestrant versus placebo plus fulvestrant in heregulin positive breast cancerHormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast CancerMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2017-000565-76-BEMerrimack Pharmaceuticals, Inc.80
进行中（未招募）
1 期
Study of seribantumab plus fulvestrant versus placebo plus fulvestrant in heregulin positive breast cancerHormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast CancerMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000020826EUCTR2017-000565-76-ESMerrimack Pharmaceuticals, Inc.80
招募中
2 期
SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancerwith KRAS G12C mutatioACTRN12622000973718The University of Sydney52