# Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer

Source: https://onco.cc/key-papers/paper-trastuzumab-breast-her2-positive-n-engl-j-med-2005/  
OnCo record `paper-trastuzumab-breast-her2-positive-n-engl-j-med-2005` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Phase 2 or 3 results paper on Trastuzumab in HER2-positive breast cancer, in New England Journal of Medicine (2005), one of the most cited Europe PMC records with Trastuzumab in its title.

## Summary

Background: We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer.

Methods: The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks (group 1) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel (group 2). The North Central Cancer Treatment Group trial N9831 compared three regimens: doxorubicin and cyclophosphamide followed by weekly paclitaxel (group A), the same regimen followed by 52 weeks of trastuzumab after paclitaxel (group B), and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel (group C). The studies were amended to include a joint analysis comparing groups 1 and A (the control group) with groups 2 and C (the trastuzumab group). Group B was excluded because trastuzumab was not given concurrently with paclitaxel.

Results: By March 15, 2005, 394 events (recurrent, second primary cancer, or death before recurrence) had been reported, triggering the first scheduled interim analysis. Of these, 133 were in the trastuzumab group and 261 in the control group (hazard ratio, 0.48; P<0.0001). This result crossed the early stopping boundary. The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years. Trastuzumab therapy was associated with a 33 percent reduction in the risk of death (P=0.015). The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831.

Conclusions: Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer. (ClinicalTrials.gov numbers, NCT00004067 and NCT00005970.)

Indexed on Europe PMC as PubMed record 16236738 (DOI 10.1056/nejmoa052122). Its title names Trastuzumab and its text names HER2-positive breast cancer; PubMed types it as a clinical trial report (Comparative Study, Clinical Trial, Research Support, U.S. Gov't, P.H.S., Research Support, Non-U.S. Gov't, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural). It was matched automatically to the idea "Can T-DXd alone cure early HER2-positive disease?" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2005
- DOI: 10.1056/nejmoa052122
- Authors: Romond EH, Perez EA, Bryant J, et al.
- What it means: One of the most cited trial reports Europe PMC returns for Trastuzumab in HER2-positive breast cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by Trastuzumab in the title and HER2-positive breast cancer in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper.

## Sources

- N Engl J Med 2005: https://doi.org/10.1056/nejmoa052122
- PubMed: https://pubmed.ncbi.nlm.nih.gov/16236738/
- Europe PMC: https://europepmc.org/article/MED/16236738

## Connected records

- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- ideas: [Can T-DXd alone cure early HER2-positive disease?](https://onco.cc/ideas/idea-tdxd-first-then-nothing/)

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