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anastrazole

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Jun 13, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment208

FDA Designations

No designations recorded

Clinical trial landscape

anastrazole · 1 trial · 1 indication

Phase 3 1
NCT00022672A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast CancerBreast Cancer
COMPLETED208 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
24 Months, End of Study (Up to 5 years)

PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm\^2) an increase of 1.0 cm\^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.

Secondary Endpoints

Percentage of Participants With Clinical Benefit
24 Months, End of Study (Up to 5 years)
Duration of Response at 24 Months
24 Months
Time to Response at 24 Months
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
trastuzumab + anastrozoleEXPERIMENTALTrastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
anastrozoleACTIVE_COMPARATOR1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Interventions

NameTypeDescription
trastuzumab (Herceptin®)DRUG4mg/kg iv loading dose, followed by 2mg/kg iv weekly
anastrazole (Arimidex®)DRUG1 mg tablet taken orally daily
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: * postmenopausal women; * metastatic breast cancer suitable for endocrine therapy; * positive hormone receptor status; * Human epidermal growth factor receptor 2 (HER2) overexpression. Exclusion Criteria: * patients on hormone replacement therapy; * previous chemotherapy for m...

Countries:United StatesAustraliaBrazilBulgariaCanadaChinaFranceGermanyHong KongHungaryIndiaIsraelItalyLithuaniaMexicoNetherlandsNorwayPolandRussiaSouth AfricaSpainSwedenTaiwanTurkey (Türkiye)UkraineUnited Kingdom
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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 anastrazole

What is anastrozole used for in breast cancer?

Anastrozole is an aromatase inhibitor used in the treatment of breast cancer. It is being studied in combination with trastuzumab (Herceptin) compared to anastrozole alone in patients with metastatic breast cancer. The drug is a small molecule developed by Roche Holding AG.

What does anastrozole target?

Anastrozole is an aromatase inhibitor, which means it works by inhibiting the aromatase enzyme. This enzyme is involved in the production of estrogen, and by blocking it, anastrozole reduces estrogen levels, which can help slow the growth of hormone-sensitive breast cancer.

Who makes anastrozole?

Anastrozole is developed by Roche Holding AG, a company traded under the ticker RHHBY. The drug is being investigated for use in breast cancer, specifically in combination with trastuzumab for metastatic breast cancer.

What phase is anastrozole in?

Anastrozole is in Phase 3 clinical development. It is an investigational drug for breast cancer, and it is not yet approved for this indication. The Phase 3 trial has been completed, with 208 patients enrolled.

What clinical trials is anastrozole in?

Anastrozole has been studied in a Phase 3 clinical trial with the identifier NCT00022672. This trial evaluated the efficacy and safety of anastrozole in combination with trastuzumab compared to anastrozole alone in patients with metastatic breast cancer. The trial has been completed.

Is anastrozole the same as Arimidex?

Yes, anastrozole is the same as Arimidex. In the clinical trial NCT00022672, anastrozole is referred to as Arimidex, which is a brand name for the drug. The trial compares the combination of Herceptin (trastuzumab) with Arimidex (anastrozole) to Arimidex alone.