# APHINITY

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

## TL;DR

Adding pertuzumab after surgery helps women whose cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease.

## Summary

APHINITY, trial NCT01358877 sponsored by Roche and the Breast International Group and reported in 2017, showed that adding pertuzumab to trastuzumab and chemotherapy after surgery helps women whose HER2-positive breast cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease. It randomised 4,805 women and met its primary invasive disease-free survival endpoint at eight years with a modest overall effect, an absolute gain of about five points in node-positive disease and none in node-negative disease, while overall survival was not significantly different, leading to pertuzumab's restriction to higher-risk disease. Whether a few points of disease-free survival justify a year of an expensive antibody is the question it left.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01358877
- Phase: 3
- Setting: Adjuvant HER2+ early breast cancer: pertuzumab + trastuzumab + chemotherapy vs placebo + trastuzumab + chemotherapy
- Sponsor: Roche / BIG
- Enrolled: 4805
- Result: 8-year iDFS HR 0.78; node-positive absolute +4.9%.
- Outcomes: 8-year invasive disease-free survival: Pertuzumab arm 88.4% vs Placebo arm 85.8%, HR 0.78
- Replication: Consistent with neoadjuvant pCR data (NeoSphere, TRYPHAENA); OS benefit not shown.

## Sources

- ClinicalTrials.gov NCT01358877: https://clinicaltrials.gov/study/NCT01358877

## 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: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- drugs: [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [Breast Cancer Trials](https://onco.cc/companies/breast-cancer-trials/)
- people: [David Cameron](https://onco.cc/people/david-cameron/)
- key papers: [Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update](https://onco.cc/key-papers/paper-aphinity-j-clin-oncol-2024-update/), [APHINITY: adjuvant pertuzumab added to trastuzumab and chemotherapy in early HER2-positive breast cancer](https://onco.cc/key-papers/paper-aphinity-nejm-2017/)
- terms: [Dual HER2 blockade](https://onco.cc/terms/dual-her2-blockade/), [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/)

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