# Adjuvant trastuzumab in HER2-positive breast cancer

Source: https://onco.cc/key-papers/paper-trastuzumab-breast-her2-positive-n-engl-j-med-2011/  
OnCo record `paper-trastuzumab-breast-her2-positive-n-engl-j-med-2011` (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 (2011), one of the most cited Europe PMC records with Trastuzumab in its title.

## Summary

Background: Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab.

Methods: We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety.

Results: At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study.

Conclusions: The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).

Indexed on Europe PMC as PubMed record 21991949 (DOI 10.1056/nejmoa0910383). Its title names Trastuzumab and its text names HER2-positive breast cancer; PubMed types it as a clinical trial report (Research Support, Non-U.S. Gov't, research-article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S., 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: 2011
- DOI: 10.1056/nejmoa0910383
- Authors: Slamon D, Eiermann W, Robert N, 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 2011: https://doi.org/10.1056/nejmoa0910383
- PubMed: https://pubmed.ncbi.nlm.nih.gov/21991949/
- Europe PMC: https://europepmc.org/article/MED/21991949

## 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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