FUnctional selection of advanced breast cancer patients for Talazoparib treatment Using the REpair Capacity (RECAP) test: The FUTURE trial

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 66

Inclusion Criteria

? Age =18 years
? WHO performance status 0-2
? Advanced breast cancer
? Patients must have (had) a high grade (Bloom & Richardson grade 3) ER positive (>10%) and HER2 negative primary breast cancer or a triple negative (ER/PR<10%, HER2 negative) primary breast cancer or breast cancer and a BRCA1 and/or BRCA2 germline 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-thorax) and bone metastases (not suitable for RECAP test because calcifications interfere with experimental procedures) are excluded. Use of low molecular weight heparin (LMWH) should be interrupted shortly before biopsy is scheduled, unless this is not necessary according to local protocols or after consent of the intervention radiologist
? The tumor must be HRD, as identified by the RECAP test
? 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 and INR <1.5, unless platelet/INR values are not necessary according to local protocols or after consent of the intervention radiologist for that particular site of biopsy (e.g. biopsy of the skin)
? Bilirubin <1.5 ULN and both AST and ALT <5x ULN in case a liver biopsy is planned
? Renal function as defined by serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min (by Cockcroft-Gault formula);
? Written informed consent
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

? Any psychological condition potentially hampering compliance with the study protocol
? 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 x8 Gy for pain palliation, then seven days interval after the last radiation should be maintained
? Patients who have received a PARP inhibitor previously for advanced setting
? 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 if all other in- and exclusion criteria are obeyed

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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