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Adding a second HER2 antibody, pertuzumab, extended survival by 16 months, the largest gain ever seen in metastatic breast cancer at the time.
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.
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.
808 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Pertuzumab + trastuzumab + docetaxel | 402 | 18.7 months | 0.68 (0.58 to 0.8) | - | link |
| Placebo + trastuzumab + docetaxel | 406 | 12.4 months | ||||
| Overall survival (final) | Pertuzumab arm | - | 57.1 months | 0.69 (0.58 to 0.82) | - | link |
| Placebo arm | - | 40.8 months |
A second publication from the CLEOPATRA 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 NCT00567190 with the most citations, so it is the natural first reading for anyone following the CLEOPATRA 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 Dual HER2 blockade, Pertuzumab, Trastuzumab, HER2-positive breast cancer.
Shares Pertuzumab, Trastuzumab, Docetaxel, HER2-positive breast cancer.
Shares Dual HER2 blockade, Pertuzumab, Trastuzumab, HER2.
Shares Pertuzumab, Trastuzumab, Roche / Genentech, Docetaxel.
Shares Pertuzumab, Trastuzumab, Docetaxel, HER2-positive breast cancer.
Shares Pertuzumab, Trastuzumab, Roche / Genentech, Docetaxel.
Shares Pertuzumab, Trastuzumab, Docetaxel, HER2-positive breast cancer.
Shares Dual HER2 blockade, Pertuzumab, Trastuzumab, HER2-positive breast cancer.