# NeoPACT

Source: https://onco.cc/trials/neopact/  
OnCo record `neopact` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

NeoPACT tested a shorter, anthracycline-free pre-operative combination of carboplatin, docetaxel and pembrolizumab in triple-negative breast cancer. Tumours disappeared completely in 58 percent of women and 86 percent were free of events at three years, which is the basis for the SCARLET phase 3 comparison with the KEYNOTE-522 regimen.

## Summary

NeoPACT (NCT03639948) was a single-arm phase 2 trial of 115 eligible patients (120 registered) with stage I to III triple-negative breast cancer enrolled from 2018 to 2022 at two US sites, who received neoadjuvant carboplatin AUC 6 and docetaxel 75 mg/m2 with pembrolizumab 200 mg every 21 days for six cycles with growth-factor support. Pathological complete response was 58 percent (95 percent confidence interval 48 to 67) and residual cancer burden 0 or 1 was 69 percent; grade 3 or higher immune-mediated adverse events occurred in 3.5 percent. Estimated three-year event-free survival was 86 percent overall, 98 percent after pathological complete response and 68 percent without it. Stromal TILs, PD-L1, the DNA damage immune response signature and the 27-gene tumour immune microenvironment signature each independently predicted response. The regimen is now the experimental arm of SWOG S2212 (SCARLET), which randomises it against the KEYNOTE-522 regimen with response-adapted adjuvant therapy in 2,400 patients.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Registry id: NCT03639948
- Phase: 2
- Setting: Stage I to III triple-negative breast cancer: neoadjuvant carboplatin and docetaxel with pembrolizumab for six cycles, anthracycline-free, single arm, two US sites
- Sponsor: University of Kansas Medical Center, with Merck
- Enrolled: 120
- Result: pCR 58% (48 to 67); RCB 0 or 1 69%; 3-year EFS 86% (98% with pCR, 68% without).
- Outcomes: Pathological complete response: Carboplatin + docetaxel + pembrolizumab 58%; Event-free survival at 3 years: All patients 86% vs Pathological complete response 98% vs No pathological complete response 68%
- Replication: Being tested against the KEYNOTE-522 regimen in SWOG S2212 (SCARLET).

## Sources

- ClinicalTrials.gov NCT03639948: https://clinicaltrials.gov/study/NCT03639948
- Sharma et al., JAMA Oncology 2024: NeoPACT clinical and biomarker findings: https://doi.org/10.1001/jamaoncol.2023.5033

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Docetaxel](https://onco.cc/drugs/docetaxel/), [Pegfilgrastim](https://onco.cc/drugs/pegfilgrastim/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- terms: [De-escalation, escalation and response-adapted therapy](https://onco.cc/terms/de-escalation/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/), [Tumour-infiltrating lymphocytes (TILs)](https://onco.cc/terms/tils/)
- trials: [KEYNOTE-522](https://onco.cc/trials/keynote-522/), [SCARLET (SWOG S2212)](https://onco.cc/trials/scarlet-s2212/)

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