# NeoSphere

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

## TL;DR

NeoSphere showed that blocking HER2 with two antibodies, pertuzumab and trastuzumab, alongside chemotherapy before surgery made HER2-positive breast tumours disappear completely more often than one antibody alone, which led to the first approval of a cancer drug for use before surgery.

## Summary

NeoSphere was an open-label randomised phase 2 trial in women with operable, locally advanced or inflammatory HER2-positive breast cancer. Four neoadjuvant arms were compared: trastuzumab plus docetaxel; pertuzumab, trastuzumab and docetaxel; pertuzumab plus trastuzumab without chemotherapy; and pertuzumab plus docetaxel. All patients had surgery followed by anthracycline chemotherapy and a year of trastuzumab.

The pertuzumab, trastuzumab and docetaxel arm had a significantly higher pathological complete response rate than trastuzumab plus docetaxel, the primary endpoint, and the chemotherapy-free antibody pair produced complete responses in a minority of patients. Together with TRYPHAENA, NeoSphere supported the accelerated approval of neoadjuvant pertuzumab in the United States in September 2013, the first drug approved on a neoadjuvant pathological response endpoint; five-year follow-up showed the pathological response tracked with fewer recurrences.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT00545688
- Phase: 2
- Setting: Operable, locally advanced or inflammatory HER2-positive breast cancer before surgery: trastuzumab with docetaxel, pertuzumab and trastuzumab with docetaxel, pertuzumab and trastuzumab without chemotherapy, or pertuzumab with docetaxel
- Sponsor: Roche
- Enrolled: 417
- Result: Pertuzumab added to trastuzumab and docetaxel raised the pathological complete response rate in HER2-positive breast cancer; neoadjuvant pertuzumab received accelerated approval in September 2013.
- Outcomes: Pathological complete response in the breast: Pertuzumab + trastuzumab + docetaxel (group B) 45.8% vs Trastuzumab + docetaxel (group A) 29% vs Pertuzumab + docetaxel (group D) 24% vs Pertuzumab + trastuzumab, no chemotherapy (group C) 16.8%

## Sources

- ClinicalTrials.gov NCT00545688: https://clinicaltrials.gov/study/NCT00545688

## 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: [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: [Luca Gianni](https://onco.cc/people/luca-gianni/)
- key papers: [5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial](https://onco.cc/key-papers/paper-neosphere-lancet-oncol-2016-update/), [Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial](https://onco.cc/key-papers/paper-neosphere-lancet-oncol-2012/)

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