EUCTR2012-000394-23-DE进行中（未招募）不适用
A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer - SOLTI NEOERIBULI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- SOLTI
- 入组人数
- 200
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
- 性别
- All
入选标准
- •1. Written IC must be given according to ICH/GCP guidelines and national/local regulations before patient registration, specifically highlighting the generation of molecular characterization of tumor and genomic samples.
- •2. Age =18 years.
- •3. Histologically confirmed invasive breast carcinoma with all of the following characteristics:
- •a. Primary tumor =2 cm in largest diameter (cT1-3) assessed by physical examination and mammography and/or breast US and/or breast MRI (where available). If the tumor is not palpable or measures less than 2 cm in physical examination, the patient is eligible if the imaging technique (mammography and/or breast US and/or breast MRI) shows a tumor of at least 2 cm.
- •b. cN0-1: patients with clinically evident axillary lymph nodes can be included, but not if metastasis in ipsilateral level I/II axillary lymph nodes are fixed to one another (matted) or to other structures (N2a). Patients with clinically involved internal mammary or supraclavicular nodes (i.e., cN2b-3) are also excluded.
- •c. No evidence of distant metastasis (M0).
- •4. BC must be eligible for definitive primary surgery.
- •5. Available pre-treatment core (Tru-cut) biopsy or possibility of performing one.
- •6. HER2- BC (as per local assessment), defined by any of the following:
- •a. 0-1+ expression by IHC.
- •b. 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene amplification (<4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to Cr17 signals] of <1.8).
- •c. Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC.
- •7. Known hormone receptor (ER/PgR) status (as per local assessment) or possibility of performing the tests.
- •8. Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests.
- •9. Multifocal tumors (defined as the presence of two or more foci of cancer within the same breast quadrant) are allowed. However, if a multifocal tumor is present:
- •a. The largest lesion must be =2 cm. It will be considered as the target lesion for all subsequent tumor evaluations.
- •b. HER2- status must be documented in all the tumor foci.
- •c. ER/PgR status of the target lesion will be considered to classify the BC subtype, as determined by IHC criteria.
- •10. ECOG performance status of 0 or 1 (see Appendix B for definitions).
- •11. Adequate laboratory values as follows:
- •a. Absolute neutrophil count (ANC) =1.5 x 109/L.
- •b. Platelets count =100 x 109/L.
- •c. Hemoglobin =9 g/dL.
- •d. Serum bilirubin =1.5 time the upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (<2 x ULN) is allowed.
- •e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN.
- •f. Alkaline phosphatase (AP) =2.5 x ULN.
- •g. Serum creatinine =1.5 mg/dL or calculated creatinine clearance =60 mL/m.
- •12. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •13. Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol; those conditions should be discussed with the patient before registration in the trial.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Any prior treatment for primary invasive BC.
- •2. Metastatic, locally advanced, or inflammatory BC (i.e., Stage III or IV BC).
- •3. Bilateral invasive BC.
- •4. Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast.
- •5. Pre-existing peripheral neuropathy of any grade.
- •6. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100mmHg).
- •7. Clinically significant (i.e., active) cardiovascular disease, including cerebrovascular accident (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, New York Heart Association = grade 2 congestive heart failure, serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment, or not controlled by medication.
- •8. Long QT syndrome.
- •9. Concomitant use of inhibitors of hepatic transport proteins, such as organic anion-transporting proteins (OATPs), P-glycoprotein (Pgp), multidrug resistant proteins (MRPs), etc. Inhibitors of such transporters include but are not limited to: cyclosporine, ritonavir, saquinavir, lopinavir, and certain other protease inhibitors, efavirenz, emtricitabine, verapamil, clarithromycin, quinine, quinidine and disopyramide.
- •10. Major medical conditions that might affect study participation (e.g., active peptic ulcer disease, uncontrolled diabetes mellitus, uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection).
- •11. Other primary malignant tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •12. Known human immunodeficiency virus (HIV) infection or other active or serious infection requiring IV antibiotics at enrollment.
- •13. Pregnancy or breastfeeding women.
- •14. Women of childbearing potential (<2 years after the last menstruation) not using effective, non-hormonal means of contraception (e.g., intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilized) during the study and for a period of 6 months following the last administration of study drug.
- •15. Administration of any live virus vaccine within 8 weeks preceding study entry.
- •16. Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study.
- •17. Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible.
- •18. Known hypersensitivity to the study drug or excipients.
- •19. Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
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