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# Truqap Misses Endpoints in Breast Cancer Trial
- URL: https://www.fdaweb.com/truqap-misses-endpoints-in-breast-cancer-trial/
- Published: 2024-06-18T12:00:00.000Z
- Updated: 2026-09-14T14:33:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157205

AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced or metastatic triple-negative breast cancer did not meet dual primary endpoints of improvement in overall survival versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumors harboring specific biomarker alterations (PIK3CA, AKT1 or PTEN).

“While we are disappointed in the CAPItello-290 outcome, these results will further our understanding of the role of the PI3K/AKT pathway in breast cancer as we continue our clinical research across the Truqap clinical development program and across our pipeline,” a company release says.

Truqap’s safety profile for its combination use with paclitaxel in CAPItello-290 was “broadly consistent with the known safety profile” of each drug, AstraZeneca says, adding that no new safety concerns were identified. The drug is also currently being evaluated in Phase 3 trials in breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with standard treatments.

Truqap is described as a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). It is currently approved in the U.S. for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen.