The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Niraparib, once daily
Objective response rate
Complete or partial tumour response according to RECIST 1.1 criteria accounting for objective response rate in solid tumours at 4 cycles., based on the CT-Scan
Time frame: 4 months
Progression-free survival
Time from inclusion to progression or death (all-cause) or last follow-up whichever occurs first
Time frame: 12 months
Overall survival
Time from inclusion to death (all-cause) or last follow-up whichever occurs first
Time frame: 12 months
Tumoral response
Partial Response or Complete Response or Stable Disease, as per to RECIST 1.1 criteria for tumoral response, based on CT-Scan
Time frame: 12 months
Duration of response
Time to treatment failure, defined as time between inclusion and treatment discontinuation (any reason: death, disease progression, toxicity) or last follow-up
Time frame: 12 months
Adverse event rate
Adverse events (clinical and biological) between inclusion and 72 months
Time frame: 72 months
Quality of Life variation
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire, evaluated every 3 months, from inclusion to 12 month
Time frame: 12 months
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