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AT1 blocker candesartan

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 2, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

AT1 blocker candesartan · 1 trial · 1 indication

Phase 3 1
NCT00459771Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated CardiotoxicityBreast Cancer
COMPLETED210 Analytics
PHASE3COMPLETED
Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The occurrence of cardiotoxicity, defined as a decline in LVEF (MUGA) of more than 15% or a decrease of less than 15% to an absolute value below 45%.
during 1 year trastuzumab therapy and during 26 weeks after discontinuation of trastuzumab
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
CandesartanACTIVE_COMPARATORCandasartan

Interventions

NameTypeDescription
AT1 blocker candesartanDRUGAT1 blocker candesartan, 32 mg oral QD
PlaceboDRUGPlacebo, 32 mg, oral QD
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Eligibility Criteria

Age Range18 Years to 79 Years
SexFEMALE
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Women aged ≥18 years * WHO: ≤ 2 * Strongly HER2-positive breast cancer, defined as an immunohistochemistry score of 3+ using the HercepTestTM, or gene amplification by fluorescence in situ hybridization, or chromogenic in situ hybridization (CISH). * Serum creatinine \<140 umo...

Countries:Netherlands
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about AT1 blocker candesartan

What is AT1 blocker candesartan used for in breast cancer?

AT1 blocker candesartan is an investigational small molecule being studied in breast cancer. It is being evaluated in a Phase 3 clinical trial for the prevention of trastuzumab-associated cardiotoxicity in breast cancer patients. The drug is an angiotensin II receptor blocker, also known as an AT1 blocker.

What does AT1 blocker candesartan target?

AT1 blocker candesartan targets the angiotensin II type 1 receptor, also known as the AT1 receptor. By blocking this receptor, the drug may help prevent cardiotoxicity associated with trastuzumab treatment in breast cancer patients. The mechanism is being studied in a Phase 3 clinical trial.

Who makes AT1 blocker candesartan?

AT1 blocker candesartan is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 3 clinical development for breast cancer, specifically for the prevention of trastuzumab-associated cardiotoxicity.

What phase is AT1 blocker candesartan in?

AT1 blocker candesartan is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for the prevention of trastuzumab-associated cardiotoxicity in breast cancer patients. The Phase 3 trial has been completed.

What clinical trials is AT1 blocker candesartan in?

AT1 blocker candesartan has one completed Phase 3 clinical trial, identified as NCT00459771. The trial, titled 'Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity,' enrolled 210 female breast cancer patients in the Netherlands. The study was randomized, double-blind, and placebo-controlled.

Is AT1 blocker candesartan the same as candesartan?

Yes, AT1 blocker candesartan is the same as candesartan. The drug is an angiotensin II receptor blocker, commonly referred to as an AT1 blocker. In the clinical trial context, it is being studied under the name candesartan for its potential to prevent trastuzumab-associated cardiotoxicity in breast cancer patients.