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PAKT, a UK-led trial run from Barts, found that adding the AKT-blocking tablet capivasertib to paclitaxel lengthened life in metastatic triple-negative breast cancer (19 versus 13 months), most clearly in tumours with PI3K-pathway mutations. The much larger CAPItello-290 trial then found no survival gain.
PAKT (NCT02423603) was a double-blind, placebo-controlled randomised phase 2 trial sponsored by Queen Mary University of London with AstraZeneca and Cancer Research UK, which randomised 140 women with untreated metastatic triple-negative breast cancer 1 to 1 to paclitaxel 90 mg/m2 on days 1, 8 and 15 with capivasertib 400 mg or placebo twice daily on days 2 to 5, 9 to 12 and 16 to 19 of 28. Median progression-free survival was 5.9 versus 4.2 months (hazard ratio 0.74, 95 percent confidence interval 0.50 to 1.08, one-sided p 0.06 against a predefined level of 0.10) and median overall survival 19.1 versus 12.6 months (hazard ratio 0.61, 0.37 to 0.99, p 0.04). In the 28 patients with PIK3CA, AKT1 or PTEN-altered tumours median progression-free survival was 9.3 versus 3.7 months (hazard ratio 0.30, 0.11 to 0.79). Grade 3 or higher diarrhoea was 13 versus 1 percent. The trial recruited at 30 UK hospitals from Bangor and Belfast to the Royal Marsden and set up CAPItello-290, the 812-patient phase 3 with the same regimen, which in 2026 reported no overall survival difference in either the overall or the pathway-altered population.
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.
140 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Capivasertib + paclitaxel | 70 | 5.9 months | 0.74 (0.5 to 1.08) | 0.06 (one-sided; predefined level 0.10) | link |
| Placebo + paclitaxel | 70 | 4.2 months | ||||
| Overall survival | Capivasertib + paclitaxel | - | 19.1 months | 0.61 (0.37 to 0.99) | 0.04 | link |
| Placebo + paclitaxel | - | 12.6 months | ||||
| Progression-free survival, PIK3CA/AKT1/PTEN-altered tumours | Capivasertib + paclitaxel | - | 9.3 months | 0.3 (0.11 to 0.79) | 0.01 | link |
| Placebo + paclitaxel | - | 3.7 months |
Shares PTEN, AKT, Capivasertib, PIK3CA / PI3K-alpha.
Shares IPATunity130, Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC, AKT, PI3K, AKT and mTOR inhibitors.
Shares Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC, AKT, Capivasertib, PI3K / AKT / mTOR.
Shares PTEN, AKT, PI3K / AKT / mTOR, Metastatic triple-negative breast cancer.
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Cytotoxic chemotherapy.
Shares AKT, Capivasertib, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR.
Shares AKT, PI3K, AKT and mTOR inhibitors, Capivasertib, PIK3CA / PI3K-alpha.
Shares AKT, PI3K, AKT and mTOR inhibitors, Capivasertib, PI3K / AKT / mTOR.