NL-OMON54538招募中不适用
FUnctional selection of advanced breast cancer patients for Talazoparib treatment Using the REpair Capacity (RECAP) test: The FUTURE trial - the FUTURE trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
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
入选标准
- •Age >=18 years
- •WHO performance status 0-2
- •Locally advanced breast cancer without curative intent or metastatic breast
- •* The breast cancer must be either
- •o high grade (Bloom & Richardson grade 3) ER positive (>10%) and HER2 negative
- •primary breast cancer, or
- •o triple negative (ER<10%, PR<10% and HER2 negative), or
- •o any Bloom & Richardson grading and receptor status and also
- •* at least one metastatic lesion must have a proven HRD phenotype based on a
- •RECAP test not treated with anticancer therapy thereafter or
- •* the patient must have a proven germline or somatic BRCA1 and/or BRCA2 mutation
- •The site of the metastatic lesion (or primary tumor in case it is still in
- •situ) should be easily amendable for biopsy. NB lung metastases (high risk of
- •hemato/pneumo-thorax) and bone metastases (not suitable for RECAP test because
- •calcifications interfere with experimental procedures) are excluded. The local
- •guidelines will be used for stopping and restarting of anticoagulation.
- •Bilirubin <1.5 ULN (except elevated bilirubin due to Gilbert*s disease or a
- •similar syndrome involving slow conjugation of bilirubin) and both AST and ALT
- •<5x ULN in case a liver biopsy is planned.
- •The tumor must be HRD, defined as HRD identified by the RECAP test determined
- •just before the start of potential Talazoparib treatment within this study or
- •just (also in case a proven germline BRCA1/2 mutation is present).
- •Maximum of four prior lines of chemotherapy for advanced disease; Patients
- •who received platinum compounds are eligible if they have had at least a
- •progression free interval of four months.
- •Measureable or evaluable disease according to RECIST 1.1 criteria (appendix 2)
- •Life expectancy >= 3 months
- •Hemoglobin >= 10 g/dL (6,2 mmol/L) and ANC of >= 1.5 x 109 /L
- •Platelets >100 x 10e9/L
- •Hepatic function as defined by total serum bilirubin <= 1. 5 x ULN (except
- •elevated bilirubin due to Gilbert*s disease or a similar syndrome involving
- •slow conjugation of bilirubin), ASAT and ALAT < 3 x ULN
- •Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine
- •clearance >= 50 mL/min (by Cockcroft-Gault formula);
- •Negative pregnancy test (urine/serum) for female patients with childbearing
- •Written informed consent
排除标准
- •Any psychological condition potentially hampering compliance with the study
- •Any treatment with investigational antitumor drugs within 28 days prior to
- •receiving the first dose of investigational treatment; or within 21 days for
- •standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic
- •regimens or endocrine therapy
- •Radiotherapy within the last four weeks prior to receiving the first dose of
- •investigational treatment; except 1 or 2 x 8 Gy for pain palliation, then seven
- •days interval after the last radiation should be maintained
- •Known persistent (>4 weeks) >= Grade 2 toxicity from prior cancer therapy
- •(except for alopecia grade 2)
- •Symptomatic brain or leptomeningeal metastases. If adequately treated with
- •resection and/or irradiation and patients are at least four weeks completely
- •free of symptoms of these metastases without the use of corticosteroids,
- •patients could be eligible
- •Women who have a positive pregnancy test (urine/serum) and/or who are
- •breastfeeding;
- •Unreliable contraceptive methods. Women and men enrolled in this trial must
- •agree to use a reliable contraceptive method throughout the study (adequate
- •contraceptive methods are: intra-uterine devices or systems, condom or other
- •barrier contraceptive measures, sterilization and true abstinence)
- •Concomitant use with P-gp inhibitors or inducers or BCRP inhibitors
- •Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia
- •Uncontrolled infectious disease (such as Human Immunodeficiency Virus
- •HIV-1 or HIV-2 infection) or known active hepatitis B or C
- •Recent myocardial infarction (< six months) or unstable angina
研究者
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