NL-OMON44691已完成不适用
Olaparib dose escalation in combination with high dose radiotherapy to the breast and regional lymph nodes in patients with breast cancer - Olaparib combined with radiotherapy in breastcancer patients
ederlands Kanker Instituut0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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
- •For group A and B
- •1. *18 years of age
- •2. Patients should fulfill all inclusion criteria for patients with the tumor present in the breast (listed under point 3) OR all inclusion criteria for postoperative patients (listed under point 4)
- •3. For patients with the tumor present in the breast:
- •a. Histological proven breast cancer or local recurrence of breast cancer which is inoperable or/and metastatic, including inflammatory breast cancer
- •b. Tumor in breast accessible for biopsy
- •4. For postoperative patients:
- •a. Histological proven BC
- •b. Mastectomy or lumpectomy that is radical or focal irradical after (re-) excision
- •c. High risk of locoregional recurrence defined as:
- •- cN2-3 & (y)pN1-3 & non-operated pre-chemo, or pre-operative in case no neoadjuvant chemotherapy is given, PET-positive or PA-proven lymph nodes;
- •- or as judged by both the principle investigator and the treating physician
- •5. WHO performance 0-2
- •6. Life expectancy of at least 6 months
- •7. Adequate hematological, renal and hepatic functions
- •a. Hemoglobin * 6.2 mmol/l
- •b. Leucocytes * 3.0 x 10E9/l
- •c. Absolute neutrophil count * 1.5x10E9/l
- •d. Platelet count * 100 x 10E9/l
- •e. Total bilirubin * 1.5 x ULN
- •f. ASAT/ALAT * 2.5 x ULN ; or in the presence of liver metastases * 5 x ULN
- •g. Creatinine clearance * 50 ml/min; measured or calculated
- •8. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 21 days of study treatment. Non-childbearing potential or postmenopausal is defined as:
- •* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •* LH and FSH levels in post menopausal range for women under 50 years of age
- •* Radiation-induced oophorectomy with last menses > 1 year ago
- •* Chemotherapy-induced menopause with > 1 year interval since last menses
- •* Surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •9 Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards
- •10. Signed written informed consent
- •For arm A only:
- •11a Indication for breast irradiation without the use of skin bolus
- •For arm B only:
- •11b Indication for breast irradiation with the use of skin bolus
排除标准
- •1. Anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy or use of other investigational agents within 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin ornitrosourea). Patient may continue the use of tamoxifen, aromatase inhibitor and LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids. The use of denosumab for bone disease is not allowed.
- •2. Major surgery within two weeks of starting study treatment.
- •3. Participation in other trial with investigational drug or treatment modality
- •4. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required.
- •5. Prior ipsilateral radiotherapy to the chest or breast.
- •6. Blood transfusion in the four weeks prior to study entry
- •7. Persistent toxicities (CTC * grade 2) with the exception of alopecia, caused by previous cancer therapy
- •8. QT-interval >470 msec
- •9. Significant cardiovascular disease as defined by
- •a. History of congestive heart failure defined as NYHA class III
- •b. History of unstable angina pectoris or myocardial infarction up to 3 months prior to trial entry;
- •c. Presence of severe valvular heart disease
- •d. Presence of a ventricular arrhythmia requiring treatment;
- •e. Uncontrolled hypertension
- •10. Patients considered a poor medical risk due to:
- •a. non-malignant systemic disease
- •b. active, uncontrolled infection requiring parenteral antibiotics
- •c. a serious, uncontrolled medical disorder; examples include, but are not limited to:
- •i. uncontrolled major seizure disorder
- •ii. unstable spinal cord compression
- •iii. superior vena cava syndrome
- •iv. extensive bilateral lung disease on HRCT scan
- •v. any psychiatric disorder that prohibits obtaining informed consent.
- •11. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •12. Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- •13. Patients with known active hepatic disease (i.e. Hepatitis B or C)
- •14. Patients with myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML on peripheral blood smear.
- •15. Gastrointestinal disorders that may interfere with absorption of the study drug or patients who are not able to take oral medication
- •16. Concomitant medications:
- •a. Any previous treatment with a PARP inhibitor, including Olaparib
- •b. Patients receiving the following classes of inhibitors of CYP3A4 (see Section 7.4 for guidelines and wash out periods)
- •i. Azole antifungals
- •ii. Macrolide antibiotics
- •iii. Protease inhibitors
- •17. Pregnant or breast-feeding women
- •18. Breast feeding women
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