# KATHERINE

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

## TL;DR

Switching to an ADC after surgery when pre-surgery treatment left cancer behind halved the risk of recurrence and improved survival.

## Summary

KATHERINE, trial NCT01772472 sponsored by Roche and Genentech and reported in 2018, showed that switching to the antibody-drug conjugate trastuzumab emtansine after surgery, when pre-surgery treatment left HER2-positive cancer behind, halved the risk of recurrence and improved survival. It randomised 1,486 women with residual invasive disease after neoadjuvant therapy to fourteen cycles of T-DM1 or trastuzumab, met its primary invasive disease-free survival endpoint with a large effect that held at seven years, and showed an overall survival benefit. It was superseded rather than replicated, since DESTINY-Breast05 showed trastuzumab deruxtecan beats T-DM1 in the same population, and whether any patient still needs T-DM1 is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01772472
- Phase: 3
- Setting: HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DM1 vs trastuzumab for 14 cycles
- Sponsor: Roche / Genentech
- Enrolled: 1486
- Result: iDFS HR 0.50; OS HR 0.66.
- Outcomes: 3-year invasive disease-free survival: T-DM1 88.3% vs Trastuzumab 77%, HR 0.5; Overall survival (7-year): T-DM1 89.1% vs Trastuzumab 84.4%, HR 0.66
- Replication: Superseded rather than replicated: DESTINY-Breast05 showed T-DXd beats T-DM1 in the same population.

## Sources

- ClinicalTrials.gov NCT01772472: https://clinicaltrials.gov/study/NCT01772472

## 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/), [Inflammatory breast cancer](https://onco.cc/cancers/inflammatory-breast-cancer/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- drugs: [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Trastuzumab emtansine](https://onco.cc/drugs/trastuzumab-emtansine/)
- companies: [NSABP Foundation](https://onco.cc/companies/nsabp-foundation/)
- terms: [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- people: [Charles E. Geyer Jr.](https://onco.cc/people/charles-geyer/), [Eleftherios P. Mamounas](https://onco.cc/people/eleftherios-mamounas/), [Gunter von Minckwitz](https://onco.cc/people/gunter-von-minckwitz/)
- key papers: [KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment](https://onco.cc/key-papers/paper-katherine-nejm-2019/)

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