{"entity":{"id":"paper-geyer-brightness-4-year-follow-up-ann-oncol-2022","kind":"paper","name":"Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial","aka":[],"tldr":"The 4.5-year follow-up of BrighTNess showing that adding carboplatin to pre-surgery chemotherapy in 634 women cut relapse or death by about 40 percent without more second cancers, while adding the PARP inhibitor veliparib added nothing.","summary":"Geyer, Sikov, Huober, Rugo and colleagues report follow-up of BrighTNess, in which 634 women with untreated stage II to III triple-negative breast cancer were randomised 2:1:1 to weekly paclitaxel with carboplatin plus veliparib (316), carboplatin plus placebo (160) or placebo alone (158), all followed by doxorubicin and cyclophosphamide. The co-primary endpoint of higher pathological complete response with veliparib was not met, so survival analyses are descriptive. At a median 4.5 years the event-free survival hazard ratio for carboplatin plus veliparib versus paclitaxel alone was 0.63 (95 percent confidence interval 0.43 to 0.92, p=0.02) but 1.12 (0.72 to 1.72) versus carboplatin without veliparib; post hoc, carboplatin versus paclitaxel alone gave 0.57 (0.36 to 0.91, p=0.02). Overall survival and rates of myelodysplastic syndrome, acute myeloid leukaemia and other second malignancies did not differ between arms.","asOf":"2026-09-24","links":[{"label":"Ann Oncol 2022","url":"https://doi.org/10.1016/j.annonc.2022.01.009"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/35093516/"},{"label":"ClinicalTrials.gov NCT02032277","url":"https://clinicaltrials.gov/study/NCT02032277"}],"tags":["tnbc-evidence"],"related":["paper-brightness-lancet-oncol-2018"],"cancers":["tnbc"],"sections":[],"technologies":["platinum","parp-inhibitor"],"targets":[],"drugs":["carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":["efs","pcr"],"trials":["brightness"],"people":["charles-geyer","hope-rugo"],"bottlenecks":[],"keyPapers":[],"journals":["annals-of-oncology"],"dependsOn":[],"notes":[],"journal":"Annals of Oncology","year":2022,"doi":"10.1016/j.annonc.2022.01.009","pmid":"35093516","authors":"Geyer CE, Sikov WM, Huober J, et al.","paperType":"rct","findings":["Event-free survival, carboplatin plus veliparib vs paclitaxel alone: hazard ratio 0.63 (95 percent CI 0.43 to 0.92), p=0.02; vs carboplatin alone 1.12 (0.72 to 1.72).","Post hoc, carboplatin vs paclitaxel alone: 0.57 (0.36 to 0.91), p=0.02.","No difference in overall survival or in myelodysplastic syndrome, acute myeloid leukaemia or other second cancers."],"whatItMeans":"The third trial to show carboplatin's benefit persists beyond pathological complete response and the trial that closed the neoadjuvant PARP inhibitor route in unselected triple-negative disease; PARP inhibition survives only in germline BRCA carriers.","caveats":["Survival analyses descriptive because the veliparib co-primary endpoint failed.","Carboplatin-alone comparison is post hoc."],"changedPractice":true,"participants":634},"route":"/key-papers/paper-geyer-brightness-4-year-follow-up-ann-oncol-2022/","neighbours":{"paper":[{"id":"paper-brightness-lancet-oncol-2018","kind":"paper","name":"Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial","route":"/key-papers/paper-brightness-lancet-oncol-2018/"}],"cancer":[{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}],"trial":[{"id":"brightness","kind":"trial","name":"BrighTNess","route":"/trials/brightness/"}],"person":[{"id":"charles-geyer","kind":"person","name":"Charles E. Geyer Jr.","route":"/people/charles-geyer/"},{"id":"hope-rugo","kind":"person","name":"Hope S. Rugo","route":"/people/hope-rugo/"}],"journal":[{"id":"annals-of-oncology","kind":"journal","name":"Annals of Oncology","route":"/journals/annals-of-oncology/"}],"roadmap":[{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}]}}