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dc.contributor.authorTurner, NC
dc.contributor.authorTelli, ML
dc.contributor.authorRugo, HS
dc.contributor.authorMailliez, A
dc.contributor.authorEttl, J
dc.contributor.authorGrischke, E-M
dc.contributor.authorMina, LA
dc.contributor.authorBalmaña, J
dc.contributor.authorFasching, PA
dc.contributor.authorHurvitz, SA
dc.contributor.authorWardley, AM
dc.contributor.authorChappey, C
dc.contributor.authorHannah, AL
dc.contributor.authorRobson, ME
dc.contributor.authorABRAZO Study Group
dc.date.accessioned2019-01-04T10:40:15Z
dc.date.issued2019-05
dc.identifier.citationClinical cancer research : an official journal of the American Association for Cancer Research, 2019, 25 (9), pp. 2717 - 2724
dc.identifier.issn1078-0432
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2991
dc.identifier.eissn1557-3265
dc.identifier.doi10.1158/1078-0432.ccr-18-1891
dc.description.abstractPURPOSE:To assess talazoparib activity in germline BRCA1/2 mutation carriers with advanced breast cancer. PATIENTS AND METHODS:ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline BRCA mutation carriers with a response to prior platinum with no progression on or within 8 weeks of the last platinum dose (cohort 1) or ≥3 platinum-free cytotoxic regimens (cohort 2) for advanced breast cancer. Primary endpoint was confirmed objective response rate (ORR) by independent radiological assessment. RESULTS:We enrolled 84 patients (cohort 1, n = 49; cohort 2, n = 35) from May 2014 to February 2016. Median age was 50 (range, 31-75) years. Triple-negative breast cancer (TNBC) incidence was 59% (cohort 1) and 17% (cohort 2). Median number of prior cytotoxic regimens for advanced breast cancer was two and four, respectively. Confirmed ORR was 21% [95% confidence interval (CI), 10-35; cohort 1] and 37% [95% CI, 22-55; cohort 2]. Median duration of response was 5.8 and 3.8 months, respectively. Confirmed ORR was 23% (BRCA1), 33% (BRCA2), 26% (TNBC), and 29% (hormone receptor-positive). The most common all-grade adverse events (AE) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in 3 (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval <8 weeks; 47% ORR with interval >6 months). CONCLUSIONS:Talazoparib exhibited promising antitumor activity in patients with advanced breast cancer and germline BRCA mutation.
dc.formatPrint-Electronic
dc.format.extent2717 - 2724
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
dc.subjectABRAZO Study Group
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectNeoplasm Metastasis
dc.subjectPlatinum
dc.subjectPhthalazines
dc.subjectBRCA1 Protein
dc.subjectBRCA2 Protein
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectPrognosis
dc.subjectSalvage Therapy
dc.subjectCohort Studies
dc.subjectFollow-Up Studies
dc.subjectDrug Resistance, Neoplasm
dc.subjectGerm-Line Mutation
dc.subjectAdult
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectPoly(ADP-ribose) Polymerase Inhibitors
dc.titleA Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO).
dc.typeJournal Article
dcterms.dateAccepted2018-12-14
rioxxterms.versionofrecord10.1158/1078-0432.ccr-18-1891
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
rioxxterms.licenseref.startdate2019-05
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfClinical cancer research : an official journal of the American Association for Cancer Research
pubs.issue9
pubs.notes6 months
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.publication-statusPublished
pubs.volume25en_US
pubs.embargo.terms6 months
icr.researchteamMolecular Oncologyen_US
dc.contributor.icrauthorTurner, Nicholasen


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