# APT (adjuvant paclitaxel-trastuzumab)

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

## TL;DR

For small HER2-positive tumours, a gentle regimen of weekly paclitaxel plus trastuzumab gives excellent cure rates, avoiding harsher chemotherapy.

## Summary

APT, trial NCT00542451 sponsored by Dana-Farber and reported in 2015, showed that for small, node-negative HER2-positive breast tumours of three centimetres or less, a gentle regimen of twelve weeks of weekly paclitaxel plus a year of trastuzumab gives excellent cure rates, avoiding harsher chemotherapy. It was a single-arm study of 410 women in which almost all remained free of disease at seven years and free of recurrence at ten, and it became the standard for stage I disease without a randomised trial. OnCo links it to paclitaxel, trastuzumab, Sara M. Tolaney and the bottleneck of wrong doses, and the ATEMPT trial of trastuzumab emtansine alone showed comparable outcomes without a toxicity advantage. Whether even less treatment, such as trastuzumab without chemotherapy, would suffice for the smallest tumours is the open question. Trastuzumab has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00542451
- Phase: 2
- Setting: Small (≤3 cm), node-negative HER2+ breast cancer: 12 weeks paclitaxel + 1 year trastuzumab
- Sponsor: Dana-Farber
- Enrolled: 406
- Result: 7-year DFS 93%; 10-year RFI 96.3%.
- Outcomes: 7-year disease-free survival: Paclitaxel + trastuzumab 93%
- Replication: ATEMPT (T-DM1) as an alternative de-escalated regimen showed comparable outcomes.

## Sources

- ClinicalTrials.gov NCT00542451: https://clinicaltrials.gov/study/NCT00542451

## Connected records

- cancers: [Early HER2-positive breast cancer](https://onco.cc/cancers/her2-positive-early-breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- drugs: [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- people: [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/)
- key papers: [Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial](https://onco.cc/key-papers/paper-apt-trial-lancet-oncol-2023-update/), [APT: adjuvant paclitaxel and trastuzumab for small, node-negative HER2-positive breast cancer](https://onco.cc/key-papers/paper-apt-tolaney-nejm-2015/)
- bottlenecks: [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/)

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