# CLEOPATRA

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

## TL;DR

Adding a second HER2 antibody, pertuzumab, extended survival by 16 months, the largest gain ever seen in metastatic breast cancer at the time.

## Summary

CLEOPATRA, trial NCT00567190 sponsored by Roche and Genentech and reported in 2011, showed that adding a second HER2 antibody, pertuzumab, to trastuzumab and docetaxel as first-line treatment for HER2-positive metastatic breast cancer extended survival by more than a year, the largest gain ever seen in metastatic breast cancer at the time. It randomised 808 women, met its primary progression-free survival endpoint, and its final survival analysis and eight-year landmark confirmed a durable benefit, defining the first-line regimen known as THP until DESTINY-Breast09 in 2025. OnCo links it to HER2 as a target, pertuzumab, trastuzumab, docetaxel, the dual HER2 blockade term, Sandra M. Swain, Javier Cortés and Georgetown Lombardi, and the dual blockade benefit was replicated in NeoSphere and APHINITY. Whether antibody-drug conjugates now displace THP entirely is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00567190
- Phase: 3
- Setting: First-line HER2+ metastatic breast cancer: pertuzumab + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel
- Sponsor: Roche / Genentech
- Enrolled: 808
- Result: OS 57.1 vs 40.8 months, HR 0.69.
- Outcomes: Progression-free survival: Pertuzumab + trastuzumab + docetaxel 18.7 months vs Placebo + trastuzumab + docetaxel 12.4 months, HR 0.68; Overall survival (final): Pertuzumab arm 57.1 months vs Placebo arm 40.8 months, HR 0.69
- Replication: Dual blockade benefit replicated in neoadjuvant (NeoSphere pCR) and adjuvant (APHINITY) settings.

## Sources

- ClinicalTrials.gov NCT00567190: https://clinicaltrials.gov/study/NCT00567190

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- people: [Javier Cortés](https://onco.cc/people/javier-cortes/), [Sandra M. Swain](https://onco.cc/people/sandra-swain/)
- key papers: [Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer](https://onco.cc/key-papers/paper-cleopatra-n-engl-j-med-2012/), [Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study](https://onco.cc/key-papers/paper-cleopatra-lancet-oncol-2013-update/)
- terms: [Dual HER2 blockade](https://onco.cc/terms/dual-her2-blockade/)
- institutions: [Georgetown Lombardi Comprehensive Cancer Center](https://onco.cc/institutions/georgetown-lombardi/)

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