7.3 months
(95% CI: 5.5-9.0)
with TRUQAP + fulvestrant (n=155)1
3.1 months
(95% CI: 2.0-3.7)
with fulvestrant (n=134)1
HR=0.50 (95% CI: 0.38-0.65; P<0.0001)
TRUQAP + fulvestrant:
the first and only targeted combination† to more than double mPFS vs fulvestrant alone in patients with PIK3CA, AKT1, or PTEN alterations
HR=0.50 (95% CI: 0.38-0.65; P<0.0001)
*The improvement in mPFS between TRUQAP + fulvestrant vs fulvestrant alone was calculated as 7.3/3.1=2.35.1
†TRUQAP is the targeted therapy within the combination.1
Target key drivers of disease1,3-5
TRUQAP inhibits oncogenic signaling driven by PIK3CA, AKT1, or PTEN alterations1
Demonstrated safety
Explore the tolerability profile of TRUQAP
Patients with PIK3CA mutations
76% of patients with alterations in CAPItello-291 had PIK3CA mutations1,6‡
CATEGORY 1 PREFERRED
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer recommends capivasertib (TRUQAP®) + fulvestrant as a Category 1 Preferred treatment option for HR+/HER2- aBC or mBC with at least one or more PIK3CA or AKT1 activating mutations or PTEN alterations following progression after a prior line of ET + CDK4/6i7
TEST for PIK3CA, AKT1, PTEN alterations
TREAT with TRUQAP + fulvestrant in 2L1
*The improvement in mPFS between TRUQAP + fulvestrant vs fulvestrant alone was calculated as 7.3/3.1=2.35.1
†TRUQAP is a targeted therapy in combination with fulvestrant.1
‡Includes patients whose tumors have both PIK3CA + AKT1 mutations and PIK3CA + PTEN alterations.6
2L=second line; aBC=locally advanced breast cancer not amenable to resection or radiation therapy with curative intent; AKT1=serine/threonine protein kinase 1; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; ET=endocrine therapy; HER2−=human epidermal growth factor receptor 2 negative; HR=hazard ratio; HR+=hormone receptor positive; mBC=metastatic breast cancer; mPFS=median progression-free survival; NCCN=National Comprehensive Cancer Network; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homolog.
References: 1. TRUQAP® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Data on File. US-112934. AstraZeneca Pharmaceuticals LP; 2026. 3. Mollon LE, Anderson EJ, Dean JL, et al. A systematic literature review of the prognostic and predictive value of PIK3CA mutations in HR+/HER2- metastatic breast cancer. Clin Breast Cancer. 2020;20(3):e232-e243. doi:10.1016/j.clbc.2019.08.011 4. Papadimitriou MC, Pazaiti A, Iliakopoulos K, Markouli M, Michalaki V, Papadimitriou CA. Resistance to CDK4/6 inhibition: mechanisms and strategies to overcome a therapeutic problem in the treatment of hormone receptor-positive metastatic breast cancer. Biochim Biophys Acta Mol Cell Res. 2022;1869(12):119346. doi:10.1016/j.bbamcr.2022.119346 5. Razavi P, Chang MT, Xu G, et al. The genomic landscape of endocrine-resistant advanced breast cancers. Cancer Cell. 2018;34(3):427-438.e6. doi:10.1016/j.ccell.2018.08.008 6. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070. doi:10.1056/NEJMoa2214131 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 31, 2026. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.
Hyperglycemia
TRUQAP can cause severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
The safety of TRUQAP has not been established in patients with Type 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies. Before initiating treatment with TRUQAP, test fasting glucose levels (FPG or FBG), HbA1C levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.
For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.
Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (eg, suspected serious infection or acute illness). Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.
Diarrhea
TRUQAP can cause severe diarrhea associated with dehydration
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start anti-diarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Cutaneous Adverse Reactions
TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia (PPE), and drug reaction with eosinophilia and systemic symptoms (DRESS).
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Embryo-Fetal Toxicity
Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for
1 month after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.
TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information.
ADVERSE REACTIONS
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.
INDICATIONS AND USAGE
Please see full Prescribing Information, including Patient Information for TRUQAP.
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INDICATIONS AND USAGE
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP™ (capivasertib) tablets
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