# IPATunity130

Source: https://onco.cc/trials/ipatunity130/  
OnCo record `ipatunity130` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

IPATunity130 tried to confirm a promising early signal for the AKT-blocking tablet ipatasertib with paclitaxel in triple-negative breast cancers carrying PI3K-pathway mutations. It failed: progression and survival were the same with or without the drug, and the ipatasertib programme in breast cancer ended.

## Summary

IPATunity130 (NCT03337724) was a double-blind placebo-controlled phase 3 trial whose cohort A randomised 255 taxane-eligible patients with PIK3CA, AKT1 or PTEN-altered measurable advanced triple-negative breast cancer and no prior chemotherapy for advanced disease 2 to 1 (168 to 87) between February 2018 and April 2020 to ipatasertib 400 mg on days 1 to 21 or placebo, both with paclitaxel 80 mg/m2 on days 1, 8 and 15 every 28 days. The primary endpoint, investigator-assessed progression-free survival, showed no difference (hazard ratio 1.02, 95 percent confidence interval 0.71 to 1.45; medians 7.4 versus 6.1 months), and final overall survival was 24.4 versus 24.9 months (hazard ratio 1.08, 0.73 to 1.58). Ipatasertib added grade 3 or worse diarrhoea (9 versus 2 percent) and dose reductions (39 versus 14 percent) with similar overall grade 3 or worse adverse events (51 versus 46 percent); exploratory PAM50 and Burstein subtype analyses were inconsistent. The randomised phase 2 LOTUS trial had suggested a progression-free survival gain in the biomarker-altered subgroup that this trial did not validate; with CAPItello-290 (capivasertib) it shows that PI3K, AKT or PTEN alteration does not select triple-negative tumours for AKT inhibition. UK sites (registry, 7): Velindre Cardiff, University Hospital Coventry, Beatson Glasgow, Royal Marsden London and Sutton, Derriford Plymouth, Royal Stoke.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT03337724
- Phase: 3
- Setting: PIK3CA, AKT1 or PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer, no prior chemotherapy for advanced disease: first-line paclitaxel with ipatasertib or placebo (cohort A), 30 countries including the United Kingdom
- Sponsor: Hoffmann-La Roche
- Enrolled: 255
- Result: PFS 7.4 vs 6.1 months (HR 1.02, 0.71 to 1.45); OS 24.4 vs 24.9 months (HR 1.08). Negative.
- Outcomes: Progression-free survival (investigator), cohort A: Ipatasertib + paclitaxel 7.4 months vs Placebo + paclitaxel 6.1 months, HR 1.02; Overall survival, cohort A: Ipatasertib + paclitaxel 24.4 months vs Placebo + paclitaxel 24.9 months, HR 1.08
- Replication: Failed to confirm the phase 2 LOTUS signal; CAPItello-290 with capivasertib reached the same negative conclusion for overall survival.

## Notes

- UK sites (registry, 7): Velindre Cancer Centre Cardiff, University Hospital Coventry, Beatson West of Scotland Cancer Centre Glasgow, Royal Marsden Hospital London and Sutton, Derriford Hospital Plymouth, Royal Stoke University Hospital.

## Sources

- ClinicalTrials.gov NCT03337724: https://clinicaltrials.gov/study/NCT03337724
- Dent et al., Clinical Cancer Research 2024: ipatasertib plus paclitaxel in PIK3CA/AKT1/PTEN-altered TNBC, IPATunity130 cohort A: https://doi.org/10.1158/1078-0432.CCR-24-0465

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/)
- targets: [AKT](https://onco.cc/targets/akt/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/), [PTEN](https://onco.cc/targets/pten/)
- drugs: [Ipatasertib](https://onco.cc/drugs/ipatasertib/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- trials: [BARBICAN](https://onco.cc/trials/barbican/), [Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC](https://onco.cc/trials/nct03997123/), [LOTUS](https://onco.cc/trials/lotus/), [PAKT](https://onco.cc/trials/pakt/)

---
JSON: https://onco.cc/api/v1/entities/ipatunity130.json