PTEN Deficiency
In mAPMN/S (also known as mHSPC),
PTEN deficiency is an aggressive biomarker that independently predicts poor PFS1
~1 in 4 patients with mAPMN/S prostate cancer have PTEN-deficient tumors2,3
PTEN deficiency is associated with poor responses:
PTEN loss was associated with a 67% increase in risk of disease progression
HR=1.67 (95% CI: 1.14-2.43, P=0.008)1
Patients have significantly shorter PFS
(11.9 months with PTEN deficiency vs 30.6 months without; P<0.001)1
Additionally, PTEN deficiency is associated with hallmarks of aggressive disease:
~45% of patients with Gleason Scores ≥8 have PTEN-deficient tumors4
~49% of patients with lymph node metastases have PTEN-deficient tumors5
Patients with PTEN-deficient mAPMN/S prostate cancer need a targeted treatment approach that may challenge these poor outcomes6
Biomarker Testing
In patients with mAPMN/S prostate cancer,
Test for PTEN with IHC for a clear and accurate picture of PTEN deficiency5,7
1. Conduct a biopsy
Consult with multidisciplinary team to select the appropriate site for a core needle biopsy (excluding bone metastases)3,8-10
Or perform appropriate tissue biopsy for the patient directly11
2. Order an FDA-authorized IHC test
PTEN expression in CAPItello-281 was evaluated using IHC testing12
IHC testing is highly sensitive and can quantify the lack of PTEN staining in ≥90% of cells13
FDA-authorized IHC testing can be performed by an in-house pathologist lab or sent to an external reference lab12,14,15:
Short turnaround time (average 2-10 days)15-17
Does not require specialized molecular pathology18,19
Test for PTEN deficiency to access a precision approach with TRUQAP® (capivasertib) + abi/pred12
IHC Testing Labs:
The laboratories listed are provided for informational purposes only and are not endorsed by AstraZeneca. Healthcare providers are responsible for selecting and using testing methods that are appropriate and compliant with the FDA-approved prescribing information for TRUQAP. Please refer to the current prescribing information, which specifies testing for PTEN deficiency using an FDA-authorized test.
NATIONAL COMPREHENSIVE CANCER NETWORK® (NCCN®) RECOMMENDATION
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer recommends certain biomarker testing for all patients with metastatic disease11
Discover the TRUQAP mechanism of action
See the mechanism of actionExplore the efficacy of TRUQAP
See TRUQAP efficacy dataAKT=serine/threonine protein kinase; AR=androgen receptor; IHC=immunohistochemistry; mAPMN/S=metastatic androgen pathway modulation-naïve/sensitive; mHSPC=metastatic hormone-sensitive prostate cancer; PFS=progression-free survival; PI3K=phosphoinositide 3-kinase; PTEN=phosphatase and tensin homolog.
References: 1. Zhang JY, Kong YY, Wang QF, et al. Prognostic value of PTEN in de novo diagnosed metastatic prostate cancer. Asian J Androl. 2022;24(1):50-55. doi:10.4103/aja.aja_39_21 2. Stopsack KH, Nandakumar S, Wibmer AG, et al. Oncogenic genomic alterations, clinical phenotypes, and outcomes in metastatic castration-sensitive prostate cancer. Clin Cancer Res. 2020;26(13):3230-3238. doi:10.1158/1078-0432.CCR-20-0168 3. Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016/j.annonc.2025.10.004 [including the Supplementary Appendix] 4. Lotan TL, Gurel B, Sutcliffe S, et al. PTEN protein loss by immunostaining: analytic validation and prognostic indicator for a high risk surgical cohort of prostate cancer patients. Clin Cancer Res. 2011;17(20):6563-6573. doi:10.1158/1078-0432.CCR-11-1244 5. Lotan TL, Heumann A, Rico SD, et al. PTEN loss detection in prostate cancer: comparison of PTEN immunohistochemistry and PTEN FISH in a large retrospective prostatectomy cohort. Oncotarget. 2017;8(39):65566-65576. doi:10.18632/oncotarget.19217 6. Jamaspishvili T, Berman DM, Ross AE, et al. Clinical implications of PTEN loss in prostate cancer. Nat Rev Urol. 2018;15(4):222-234. doi:10.1038/nrurol.2018.9 7. de Bono J, Sweeney C, Bracarda S, et al. PI3K/AKT pathway biomarkers analysis from the Phase III IPATential150 trial of ipatasertib plus abiraterone in metastatic castration-resistant prostate cancer. Presented at: ASCO Genitourinary Cancers Symposium; February 11, 2021. Accessed May 7, 2026. 8. Montagut C, Albanell J, Bellmunt J. Prostate cancer. Multidisciplinary approach: a key to success. Crit Rev Oncol Hematol. 2008;68 Suppl 1:S32-S36. doi:10.1016/j.critrevonc.2008.07.009 9. Sciarra A, Gentile V, Panebianco V. Multidisciplinary management of prostate cancer: how and why. Am J Clin Exp Urol. 2013;1(1):12-17. 10. UCLA Health. Targeted, MRI-guided prostate biopsy. Accessed January 14, 2026. https://www.uclahealth.org/cancer/cancer-services/prostate-cancer/diagnosis/prostate-biopsy 11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed January 23, 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. 12. TRUQAP® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 13. Cuzick J, Yang ZH, Fisher G, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013;108(12):2582-2589. doi:10.1038/bjc.2013.248 14. UC Davis Health. Histology services. Accessed January 14, 2026. https://health.ucdavis.edu/pathology/research/research_labs/histology/services.html 15. LabCorp Oncology. Immunohistochemistry (IHC). Accessed January 14, 2026. https://oncology.labcorp.com/tests/484006/immunohistochemistry-ihc 16. UC Davis Health. Specimen turnaround time. Accessed January 14, 2026. https://health.ucdavis.edu/pathology/services/clinical/anatomic_pathology/surgical pathology/clinical_services/turnaround_time.html 17. NYU Langone Health. Neuropathology services. Accessed January 14, 2026. https://med.nyu.edu/departments-institutes/pathology/clinical-services/physicians/anatomic-pathology-services/neuropathology 18. National Cancer Institute. Immunohistochemistry. Accessed January 14, 2026. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immunohistochemistry 19. Association for Molecular Pathology. What is molecular pathology? Accessed January 14, 2026. https://www.amp.org/about/what-is-molecular-pathology
See Full Indications
Plus
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
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
- In CAPItello-291, increased fasting glucose (FG) from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG >160 to 250 mg/dL), 2% with Grade 3 (FG >250 to 500 mg/dL), and 1.1% with Grade 4 (FG >500 mg/dL) events
- The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients. Diabetic metabolic decompensation occurred in 0.6% of patients, including diabetic ketoacidosis in 0.3%
- In the study, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 4.8% (17/355) of patients
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello-281, increased fasting glucose (FG) from baseline occurred in 69% of patients treated with TRUQAP, including 25% of patients with Grade 2 (FG >160 to 250 mg/dL), 12% with Grade 3 (FG >250 to 500 mg/dL), and 1.2% of patients with Grade 4 (FG >500 mg/dL) events
- The median time to first occurrence of hyperglycemia was 71 days (range: 1 to 1454). Dose reduction for hyperglycemia was required in 8.7% of patients and permanent discontinuation was required in 2.4% of patients. Diabetic ketoacidosis occurred in 1.2% of patients
- In the study, 41% (204/503) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 16% (81/503) of patients
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
- In CAPItello-291, diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients
- The median time to first occurrence was 8 days (range: 1 to 519). In the study, dose reductions were required in 8% of patients, and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ≥2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154)
- In the 257 patients with diarrhea, 59% required anti-diarrheal medications to manage symptoms
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello‑281, diarrhea of any grade occurred in 264 (52%) patients. Grade 3 occurred in 31 (6%) patients and Grade 4 occurred in 1 (0.2%) patient
- The median time to first occurrence was 12 days (range: 3 to 48). In the study, dose reductions were required in 26 (5%) patients and 6 (1.2%) patients discontinued TRUQAP due to diarrhea
- In the 264 patients with diarrhea, anti-diarrheal medication was required in 64% (170/264) of patients to manage diarrhea symptoms
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
- In CAPItello-291, cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients, and DRESS occurred in 0.3% of patients
- The median time to onset of cutaneous adverse reactions was 13 days (range: 1 to 575 days). Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions
- Among the 204 patients with cutaneous adverse reactions, 44% (90/204) required corticosteroid treatment. Of these, 37% (76/204) were treated with topical corticosteroids and 19% (39/204) with systemic corticosteroids. In patients with Grade ≥2 cutaneous adverse reaction (n=116) with at least 1 grade improvement (n=104), median time to improvement from the first event was 12 days (range: 2 to 544)
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello-281, cutaneous adverse reactions occurred in 53% of patients. Grade 3 cutaneous adverse reactions occurred in 84 (17%) patients and Grade 4 occurred in 1 (0.2%) patients
- The median time to onset of rash was 13 days (range: 11 to 63 days). In the study, dose reduction was required in 58 (12%) patients and 38 (8%) patients discontinued TRUQAP due to rash
- Among the 265 patients with cutaneous adverse reactions, 80% (212/265) required treatment and 91% (242/265) recovered in the study. Of these, 54% (115/212) were treated with topical corticosteroids and 25% (54/212) with systemic corticosteroids
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
- Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%)
- In the 155 patients with PIK3CA/AKT1/PTEN alterations treated with TRUQAP + fulvestrant, dose reductions due to adverse reactions were reported in 21% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- Among the 503 patients who received TRUQAP in CAPItello-281, the most common (≥20%) adverse reactions including laboratory abnormalities were increased fasting glucose (70%), decreased hemoglobin (61%), decreased lymphocytes (58%), cutaneous adverse reactions (53%), diarrhea (53%), decreased potassium (51%), increased creatinine (49%), increased non-fasting glucose (49%), increased alanine aminotransferase (38%), increased triglycerides (37%), increased aspartate aminotransferase (36%), decreased sodium (30%), and fatigue (26%)
- In the 503 patients treated with TRUQAP + abiraterone and prednisone, dose reductions due to adverse reactions were reported in 32% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 20% of patients. Dose interruptions of TRUQAP occurred in 65% of patients
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
- TRUQAP in combination with fulvestrant is indicated for the treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy
- TRUQAP in combination with abiraterone and prednisone is indicated for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test
Please see full Prescribing Information, including Patient Information for TRUQAP.
You may report side effects related to AstraZeneca products
.
IMPORTANT SAFETY INFORMATION
Expand
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
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
- In CAPItello-291, increased fasting glucose (FG) from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG >160 to 250 mg/dL), 2% with Grade 3 (FG >250 to 500 mg/dL), and 1.1% with Grade 4 (FG >500 mg/dL) events
- The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients. Diabetic metabolic decompensation occurred in 0.6% of patients, including diabetic ketoacidosis in 0.3%
- In the study, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 4.8% (17/355) of patients
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello-281, increased fasting glucose (FG) from baseline occurred in 69% of patients treated with TRUQAP, including 25% of patients with Grade 2 (FG >160 to 250 mg/dL), 12% with Grade 3 (FG >250 to 500 mg/dL), and 1.2% of patients with Grade 4 (FG >500 mg/dL) events
- The median time to first occurrence of hyperglycemia was 71 days (range: 1 to 1454). Dose reduction for hyperglycemia was required in 8.7% of patients and permanent discontinuation was required in 2.4% of patients. Diabetic ketoacidosis occurred in 1.2% of patients
- In the study, 41% (204/503) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 16% (81/503) of patients
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
- In CAPItello-291, diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients
- The median time to first occurrence was 8 days (range: 1 to 519). In the study, dose reductions were required in 8% of patients, and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ≥2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154)
- In the 257 patients with diarrhea, 59% required anti-diarrheal medications to manage symptoms
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello‑281, diarrhea of any grade occurred in 264 (52%) patients. Grade 3 occurred in 31 (6%) patients and Grade 4 occurred in 1 (0.2%) patient
- The median time to first occurrence was 12 days (range: 3 to 48). In the study, dose reductions were required in 26 (5%) patients and 6 (1.2%) patients discontinued TRUQAP due to diarrhea
- In the 264 patients with diarrhea, anti-diarrheal medication was required in 64% (170/264) of patients to manage diarrhea symptoms
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
- In CAPItello-291, cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients, and DRESS occurred in 0.3% of patients
- The median time to onset of cutaneous adverse reactions was 13 days (range: 1 to 575 days). Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions
- Among the 204 patients with cutaneous adverse reactions, 44% (90/204) required corticosteroid treatment. Of these, 37% (76/204) were treated with topical corticosteroids and 19% (39/204) with systemic corticosteroids. In patients with Grade ≥2 cutaneous adverse reaction (n=116) with at least 1 grade improvement (n=104), median time to improvement from the first event was 12 days (range: 2 to 544)
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- In CAPItello-281, cutaneous adverse reactions occurred in 53% of patients. Grade 3 cutaneous adverse reactions occurred in 84 (17%) patients and Grade 4 occurred in 1 (0.2%) patients
- The median time to onset of rash was 13 days (range: 11 to 63 days). In the study, dose reduction was required in 58 (12%) patients and 38 (8%) patients discontinued TRUQAP due to rash
- Among the 265 patients with cutaneous adverse reactions, 80% (212/265) required treatment and 91% (242/265) recovered in the study. Of these, 54% (115/212) were treated with topical corticosteroids and 25% (54/212) with systemic corticosteroids
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
- Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%)
- In the 155 patients with PIK3CA/AKT1/PTEN alterations treated with TRUQAP + fulvestrant, dose reductions due to adverse reactions were reported in 21% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
- Among the 503 patients who received TRUQAP in CAPItello-281, the most common (≥20%) adverse reactions including laboratory abnormalities were increased fasting glucose (70%), decreased hemoglobin (61%), decreased lymphocytes (58%), cutaneous adverse reactions (53%), diarrhea (53%), decreased potassium (51%), increased creatinine (49%), increased non-fasting glucose (49%), increased alanine aminotransferase (38%), increased triglycerides (37%), increased aspartate aminotransferase (36%), decreased sodium (30%), and fatigue (26%)
- In the 503 patients treated with TRUQAP + abiraterone and prednisone, dose reductions due to adverse reactions were reported in 32% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 20% of patients. Dose interruptions of TRUQAP occurred in 65% of patients
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
- TRUQAP in combination with fulvestrant is indicated for the treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy
- TRUQAP in combination with abiraterone and prednisone is indicated for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test
Please see full Prescribing Information, including Patient Information for TRUQAP.
You may report side effects related to AstraZeneca products.
