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IMpassion031 showed that adding the immune drug atezolizumab to chemotherapy before surgery for early triple-negative breast cancer raised the share of women whose tumour had disappeared at surgery from 41 to 58 percent, whatever their PD-L1 status.
IMpassion031, trial NCT03197935 sponsored by Roche and Genentech and published in the Lancet in 2020, randomised 333 patients with previously untreated stage II or III triple-negative breast cancer to atezolizumab or placebo with nab-paclitaxel followed by doxorubicin and cyclophosphamide before surgery, with atezolizumab or observation after. Pathological complete response rose from 41 to 58 percent in all patients and from 49 to 69 percent in the PD-L1-positive subgroup, meeting the co-primary endpoint in the whole population but not the PD-L1-positive one at the prespecified boundary, with immune-related side effects as expected. It confirmed the KEYNOTE-522 finding that immunotherapy raises response rates in early disease regardless of PD-L1, but with no event-free survival benefit shown and the withdrawal of atezolizumab from metastatic breast cancer in 2021, pembrolizumab rather than atezolizumab became the standard. Whether the platinum-free backbone or the drug explains the smaller trial's limited uptake is a matter of debate.
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.
333 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (all patients)primary | Atezolizumab + chemotherapy | 165 | 58% | - | 0.0044 | link |
| Placebo + chemotherapy | 168 | 41% |
A second publication from the IMpassion031 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 NCT03197935 with the most citations, so it is the natural first reading for anyone following the IMpassion031 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 NeoTRIP (NeoTRIPaPDL1), Pathologic complete response (pCR), Atezolizumab, Roche / Genentech.
Shares Pathologic complete response (pCR), Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem, Doxorubicin, Cyclophosphamide.
Shares Early triple-negative breast cancer, Doxorubicin, Cyclophosphamide, Paclitaxel / nab-paclitaxel.
Shares Pathologic complete response (pCR), Early triple-negative breast cancer, Doxorubicin, Cyclophosphamide.
Shares Early triple-negative breast cancer, Doxorubicin, Cyclophosphamide, Paclitaxel / nab-paclitaxel.
Shares NeoTRIP (NeoTRIPaPDL1), Atezolizumab, Roche / Genentech, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Atezolizumab, Roche / Genentech, PD-L1, Paclitaxel / nab-paclitaxel.
Shares Early triple-negative breast cancer, Doxorubicin, Cyclophosphamide, Paclitaxel / nab-paclitaxel.