BrighTNess

Design, population and eligibility

Treatment and comparator

All groups received weekly paclitaxel 80 mg/m² for 12 weeks followed by doxorubicin–cyclophosphamide (AC) for four cycles. Group 1 received carboplatin AUC 6 every 3 weeks plus veliparib 50 mg twice daily during paclitaxel; group 2 received carboplatin plus placebo; group 3 received placebo without carboplatin. Carboplatin/veliparib were given with paclitaxel only.

Primary and secondary endpoints

Primary endpoint: pCR in breast and axilla. EFS and OS were longer-term secondary outcomes; the 4.5-year analysis included post-hoc comparisons.

Key efficacy results

pCR was 53% with carboplatin–veliparib, 58% with carboplatin alone and 31% with paclitaxel alone. Adding veliparib did not improve pCR over carboplatin alone (p=0.36).

At median 4.5-year follow-up, EFS HR was 0.63 (95% CI 0.43–0.92; p=0.02) for carboplatin–veliparib versus paclitaxel alone, and 1.12 (0.72–1.72; p=0.62) for carboplatin–veliparib versus carboplatin alone. The post-hoc carboplatin-alone versus paclitaxel-alone EFS HR was 0.57 (0.36–0.91; p=0.02). OS did not differ significantly between arms.

Source-reported outcome visualization

pCR at surgery · three randomized arms.

Source-reported pCR rates. Long-term EFS signal supports carboplatin; the post-hoc comparison should be distinguished from the prespecified primary analysis.

Absolute effect

No survival NNT is established. A pCR difference is a surrogate endpoint and should not be converted into an NNT implying a proven survival gain. The post-hoc EFS HR is relative and does not provide a defensible fixed-time absolute benefit in the cited report.

Trial-specific toxicity and treatment burden

Grade 3–4 neutropenia occurred in 56%, anaemia in 29% and thrombocytopenia in 12% across the study population. Febrile neutropenia occurred in 15% during the second treatment segment; serious febrile neutropenia occurred in 13% and serious anaemia in 3%. Grade 3–4 toxicities and serious adverse events were more frequent with carboplatin; veliparib did not substantially add toxicity.

Treatment delivery was not substantially compromised, but platinum adds marrow suppression, transfusion/supportive-care burden and additional monitoring.

Quality of life and patient-reported outcomes

No definitive QoL advantage for veliparib was established. The primary reports focus on pCR, EFS, OS and safety; do not infer patient-reported benefit from response rates.

Subgroups and applicability

The long-term EFS signal with carboplatin was not accompanied by a significant OS difference. No validated biomarker subgroup identifies a population benefiting specifically from veliparib in this study.

Current-practice context · reviewed 2 November 2026

Carboplatin is commonly incorporated into neoadjuvant chemotherapy for higher-risk TNBC. In current practice, eligible stage II–III patients are also considered for pembrolizumab-containing perioperative therapy based on KEYNOTE-522; BrighTNess predates that strategy and does not test the addition of carboplatin to pembrolizumab.

Limitations and critical interpretation

The carboplatin-alone versus paclitaxel-alone EFS comparison was post hoc. OS was not significantly different. The three-arm design does not support a veliparib benefit; pCR is not a substitute for mature survival outcomes.

Bottom line: BrighTNess supports carboplatin as a component of neoadjuvant chemotherapy in stage II–III TNBC, but not veliparib. Haematologic toxicity is substantial and the EFS signal must be interpreted in the context of a post-hoc comparison and contemporary immunotherapy.

Primary sources and follow-up publications

1. BrighTNess primary report, Lancet Oncology 2018
2. BrighTNess 4.5-year follow-up, Annals of Oncology 2022
3. BrighTNess registry

All outcome values above are transcribed from the linked trial reports or their prespecified follow-up publications. Unreported values are not imputed. No NNT is derived from median survival.