KCT0004338Not yet recruiting未知
Phase II Study of Abemaciclib plus Trastuzumab biosimilar(Herzuma®) ± Fulvestrant in Patients with HER2 Positive Metastatic Breast Cancer in Brain who Progressed after HER2 directed Chemotherapy
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- Female
Inclusion Criteria
- •1. breast cancer patients with brain metastasis secondary to histologically or cytologically confirmed HER2+ amplified breast cancer by either immunohistochemistry(IHC) or in-situ hybridization(ISH).
- •a) To fulfill the requirement of HER2+ disease, the primary tumor or metastatic lesion of the breast cancer must demonstrate overexpression of HER2 by either IHC (3+) or gene amplification by positive in-situ hybridization(ISH) as defined in the relevant ASCO/CAP HER2 guidelines.
- •2. have measurable and/or non-measurable disease according to RECIST version 1.1.
- •3. patients must have received at least one regimen of systemic chemotherapy including HER2 directed agents for metastatic/recurrent disease.
- •4. patients with parenchymal brain metastasis must be stable for at least 2 weeks following whole brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS)
- •a) Patients are not required to have received prior local therapy for study participation.
- •5. patients have =1 new or not previously irradiated measurable metastatic brain lesion =10 mm in the longest diameter (LD) and =5 mm in the perpendicular plane or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd-MRI).
- •6. if receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
- •7. have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale (appendix 1).
- •8. have a life expectancy =12 weeks.
- •9. patient is an adult, female = 19 years old at the time of informed consent.
- •10. Have previously received:
- •a) prior at least one line of HER2 directed therapy including trastuzumab for metastatic disease is mandatory. prior HER2-directed therapies could be in combination with chemotherapy or endocrine therapy or as single agent.
- •b) exposure to dual HER2 blockade (for example, combination trastuzumab and pertuzuma) is considered as 1 prior HER2-directed therapy.
- •c) prior trastuzumab and/or pertuzumab and/or lapatinib are allowed in any disease setting.
- •d) patients may have received previous any endocrine therapy with fulvestrant.
- •11. have discontinued all previous therapies for cancer (including cytotoxic chemotherapy, targeted therapy [including, but not limited to, everolimus], radiotherapy, immunotherapy, and investigational therapy) for at least 14 days prior to receiving abemaciclib and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia or peripheral neuropathy.
- •12. have adequate organ function
- •a) bone marrow: a) ANC = 1.5 x 109/L; b) Platelets = 100 x 109/L; c) Hemoglobin = 8.0 g/dL
- •b) hepatic: total bilirubin = 1.5x upper normal limit(ULN) except in cases of known Gilbert’s syndrome where =2.0 times ULN is allowed) and alanine aminotransferase(ALT) and aspartate aminotransferase(AST) = 3 x ULN. If, liver metastases are present, AST and ALT = 5 x ULN are acceptable.
- •c) renal: creatinine = 1.5x ULN or CCr > 60 ml/min for patients with abnormal serum Cr level function.
- •13. must have left ventricular ejection fraction (LVEF) of 50% or higher at baseline (determined by echocardiography or multiple-gated acquisition scanning).
- •14.have postmenopausal status due to either surgical/natural menopause or induced by ovarian suppression
- •15. are reliable and willing to make themselves available for the duration of the study and are willing to foll
Exclusion Criteria
- •1. require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
- •2. are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
- •3. have evidence of significant (ie, symptomatic) intracranial hemorrhage.
- •4. have experienced >2 seizures within 4 weeks prior to study entry.
- •5. is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •6. has received previous treatment with abemaciclib
- •a) patients may have received prior palbociclib or ribociclib, but only patients without progression of CNS on palbociclib or ribociclib will be allowed.
- •7. have known contraindication to Gd-MRI.
- •8. have a personal history within the last 12 months of any ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest
- •9. have a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea.
- •10. have a history of any other cancer (except non-melanoma skin cancer, carcinoma in-situ of the cervix, thyroid cancer with no lymph node metastasis), unless in complete remission with no therapy for a minimum of 3 years.
- •11. have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies or hepatitis C antibodies). Patients have hepatitis B surface antigen are eligible if they are on pre-emptive antiviral treatment. Screening is not required for enrollment.
- •12. have an acute bacterial infection requiring intravenous (IV) antibiotics
- •13. are currently enrolled in a clinical trial involving investigational product (IP) or non-approved use of a drug or device (other than the IP/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •14. have received any recent (within 28 days prior to randomization) live virus vaccination
- •15. history of interstitial lung disease (ILD) or severe dyspnea at rest or requiring oxygen therapy
- •16. hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients.
- •17. History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency) or long-term anticoagulant therapy (although patients treated with anti-platelet therapy and low dose warfarin or other anticoagulant agents such as acenocoumarol are eligible providing they have an international normalised ratio [INR] of =1.6).
Investigators
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