EUCTR2016-004384-39-AT进行中（未招募）1 期
A prospective, open, randomized, phase II study of carboplatin/olaparib in the pre-operative treatment of patients with triple-negative primary breast cancer which exhibit the features of positive homologous recombination deficiency (HRD) status
Austrian Breast & Colorectal Cancer Study Group (ABCSG)0 个研究点目标入组 90 人开始时间: 2018年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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. Signed informed consent prior to any study specific assessments and procedures
- •2. Patients must be = 18 years of age
- •3. Pre-menopausal (incl. peri-menopausal) and postmenopausal women and men with core-biopsied, early primary triple-negative (acc. to local standards) invasive breast cancer
- •4. Positive HRD status (centrally assessed) in core-biopsy sample of the breast
- •5. Absence of distant metastasis (M0) as assessed acc. to institutional standards within 90 days prior to randomization
- •6. Unilateral early invasive TNBC patients.
- •7. Willingness to undergo adequate lymph node procedures (e.g., sentinel/ axillary lymph node dissection) acc. to institutional standards
- •8. Patients must have normal organ and bone marrow function measured within 28 days prior to randomization as defined below:
- •Haemoglobin (Hb) =10.0 g/dL
- •Absolute neutrophil count (ANC) =1.5 x 109/L
- •Absence of known Myelodysplastic Syndrome (MDS)/ Acute Myeloid Leukaemia (AML) and no features suggestive of MDS/ AML on *peripheral blood smear (*For patients randomized according to protocol version 2.0, peripheral blood smear only has to be performed if haematology assessment during screening shows abnormalities that require further clarification)
- •White blood cell (WBC) count = 3.0 x 109/L
- •Platelet count =100 x 109/L
- •Total bilirubin =1.5 x institutional upper limit of normal (ULN)
- •AST (SGOT)/ ALT (SGPT) =2.5 x institutional ULN
- •Serum creatinine =1.5 x institutional ULN or creatinine clearance using the Cockcroft-Gault equation =51 mL/min
- •9. ECOG performance status 0-1
- •10. Negative pregnancy test (serum or urine) max. 28 days prior to randomization for women with childbearing potential:
- •Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
- •11. Women of childbearing potential and male patients randomized into treatment Arm A or B must use adequate contraception for the duration of protocol treatment and for 6 months after the last dose of (N)IMP for women and 3 months for male patients. Adequate contraception is defined as one highly effective form (i.e. total abstinence, (fe)male sterilization) OR two effective forms (e.g. non-hormonal intrauterine device (IUD) and condom/occlusive cap with spermicidal foam/gel/film/cream/suppository)
- •12. Patient is willing and able to comply with the protocol for the duration of the study, incl. undergoing treatment, scheduled visits and examinations
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/ABCSG staff and/or staff at the study site)
- •2. Previous randomization in the present study
- •3. Participation in another clinical study with an investigational product during the last 6 months (i.e. 183 days) prior to randomization
- •4. Any previous treatment with a PARP inhibitor, including olaparib
- •5. Prior ipsilateral invasive breast cancer and/or ipsilateral Ductal Carcinoma in Situ (DCIS) and/or prior chemotherapy for any breast cancer
- •Patients with contralateral invasive breast cancer and/or contralateral DCIS diagnosed =5 years prior to randomization if curatively treated without chemotherapy are eligible
- •6. Bilateral invasive breast cancer
- •7. Patients with second primary malignancy are ineligible except for the following:
- •Adequately treated non-metastatic, non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, stage 1 grade 1 endometrial carcinoma or
- •Other curatively treated malignancies diagnosed =5 years prior to randomization with no evidence of disease for at least 5 years
- •8. Other severe acute and/or chronic medical and/or psychiatric condition and/or laboratory abnormality that would impart, in the judgment of the Investigator, risk associated with study participation or (N)IMP administration, or which, in the judgment of the Investigator, would make the patient inappropriate for participation in this study
- •9. Concomitant use of known strong or moderate Cytochrome P450 3A4 (CYP3A4) inducers. For further details refer to Appendix B
- •10. Resting ECG with QTc >470 msec and/ or family history of long QT syndrome
- •However, ECG measurement can be repeated within 24 hours and patient is ineligible if none of these repeated measurements demonstrate QTc =470 msec
- •11. Echocardiography (ECHO) and/or multigated acquisition (MUGA) scan with <50% Left Ventricular Ejection Fraction (LVEF)
- •12. Whole blood transfusions within 120 days prior to randomization
- •13. Major surgery within 14 days prior to randomization and/or patients with insufficient recovery from any major surgery per physician’s assessment at the time of randomization
- •14. Any medical condition rendering the patient unfit for pre-operative chemotherapy with TAC or carboplatin/olaparib
- •15. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the (N)IMP
- •16. Pregnant or breast feeding women
- •17. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) or patients who are receiving antiretroviral therapy
- •18. Patients with known active hepatic disease (i.e. Hepatitis B or C)
- •19. Patients with a known hypersensitivity to olaparib, platins, taxanes, anthracyclines, or cyclophosphamide
- •20. Patients with uncontrolled seizures
- •21. Previous allogeneic bone marrow transplant
- •22. Known = grade 2 peripheral neuropathy
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