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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
417 enrolled.
95% CI 36.1 to 55.7 · 95% CI 20.6 to 38.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response in the breastprimary | Pertuzumab + trastuzumab + docetaxel (group B) | 107 | 45.8% | - | 0.0141 (group B vs group A) | link |
| Trastuzumab + docetaxel (group A) | 107 | 29% | ||||
| Pertuzumab + docetaxel (group D) | 96 | 24% | ||||
| Pertuzumab + trastuzumab, no chemotherapy (group C) | 107 | 16.8% |
A second publication from the NeoSphere trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT00545688 with the most citations, so it is the natural first reading for anyone following the NeoSphere trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Early HER2-positive breast cancer, Trastuzumab, Roche / Genentech, HER2-positive breast cancer and the tag subtype-trials.
Shares Pertuzumab, Trastuzumab, HER2-positive breast cancer and the tag subtype-trials.
Shares Pertuzumab, Trastuzumab, Monoclonal antibodies and the tag subtype-trials.
Shares Roche / Genentech, Docetaxel and the tag subtype-trials.
Shares Roche / Genentech, Monoclonal antibodies and the tag subtype-trials.
Shares Roche / Genentech, Monoclonal antibodies and the tag subtype-trials.
Shares Roche / Genentech and the tag subtype-trials.
Shares Docetaxel and the tag subtype-trials.