germline BRCA1/2 mutation-positive metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) HER2 negative (HER2 IHC score of 0, 1 + or 2 + with FISH negative) 2)Positive for gBRCA1/2 mutations, limited to deleterious or suspected deleterious mutations only, not variants of uncertain significance (VUS) 3) Metastatic or unresectable locally advanced breast cancer 4) Falling under any of the following categories, (a) Plan to initiate olaparib treatment (b) Currently being treated with olaparib (c) Previously treated with olaparib 5) No prior use of PARP inhibitors other than olaparib 6) Aged 20 years or older at the time of obtaining consent 7) One or more measurable or non-measurable lesions found in computed tomography (CT) scan or magnetic resonance imaging (MRI) taken within 30 days of olaparib administration 8) Has provided informed consent to participate in this study
Exclusion criteria
Exclusion criteria: Any subject deemed unsuitable by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of BRCA1/2 reversion mutation in tumors with acquired resistance to olaparib | — |
Secondary
| Measure | Time frame |
|---|---|
| -Frequency of acquired resistance to olaparib by mechanisms other than reversion mutations, including 53BP1 loss, PTIP loss, SLFN11 loss, and PARG loss -Function of BRCA1/2 in cases of putative BRCA1/2 reversion mutations -Differences in the frequency of reversion mutations in BRCA1/2 by number of previous chemotherapy to olaparib | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed