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TRUQAP plus fulvestrant is indicated for the treatment of adult patients with HR+/HER2-negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally aBC or mBC with one or more PIK3CA/AKT1/PTEN alterations following recurrence or progression on or after an ET.2,3
CAPItello-291 was a Phase 3 randomised, double-blind trial of 708 patients with HR+/HER2-negative aBC that were pre-, peri- and post-menopausal women and men.1 Patients were randomly assigned in a 1:1 ratio to receive TRUQAP plus fulvestrant or placebo plus fulvestrant.1
*Patients with PIK3CA/AKT1/PTEN-altered tumours treated with TRUQAP plus fulvestrant (n=155) experienced statistically significantly longer mPFS: 7.3 months vs 3.1 months with placebo plus fulvestrant (n=134); HR 0.50, 95% CI: 0.38–0.65, P<0.001.1
Data from 355 patients who received TRUQAP plus fulvestrant in CAPItello-291 showed that adverse events were mostly grade 1 or 2.2
*Diarrhoea includes diarrhoea and frequent bowel movements.2
†Cutaneous events include butterfly rash, dermatitis, dermatitis exfoliative generalised, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema, erythema multiforme, papule, rash, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, skin reaction and toxic skin eruption.2
‡Fatigue includes asthenia, fatigue and malaise.2
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GB-68397 | April 2026
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.