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Alendronate

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 13, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment303

FDA Designations

No designations recorded

Clinical trial landscape

Alendronate · 1 trial · 1 indication

Phase 3 1
NCT00122356Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm AssessmentBreast Cancer
COMPLETED303 Analytics
PHASE3COMPLETED
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Breast Cancer
NCT00122356303
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Study Endpoints

Primary Endpoints

Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
5 years

Secondary Endpoints

Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
12 monthly intervals
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
6 months after registration and/or 6 months after commencing alendronate
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Anastrozole and alendronateOTHERPatients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.

Interventions

NameTypeDescription
Alendronate sodiumDRUG70mg tablets, once weekly
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Eligibility Criteria

SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Postmenopausal * Adequately diagnosed and treated Stage I-IIIa early breast cancer * Oestrogen receptor and/or progesterone receptor positive breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Hormone replacement therapy (HRT...

Countries:Australia
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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 Alendronate

What is Alendronate used for in breast cancer?

Alendronate is a small molecule bisphosphonate being studied for use in breast cancer. It is being investigated as part of a bone maintenance algorithm in postmenopausal women with the disease. The drug is currently in Phase 3 clinical development for this oncology indication.

Who is developing Alendronate for breast cancer?

AstraZeneca PLC (ticker: AZN) is developing Alendronate for breast cancer. The company is conducting a Phase 3 clinical trial of the drug in this indication. Alendronate is a small molecule therapeutic being evaluated in the oncology setting.

What phase is Alendronate in for breast cancer?

Alendronate is in Phase 3 clinical development for breast cancer. It is an investigational drug and has not been approved for this use. One Phase 3 trial has been completed, and the drug is being evaluated in postmenopausal women with breast cancer.

What clinical trials is Alendronate in for breast cancer?

Alendronate is being studied in clinical trial NCT00122356, titled "Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment." This Phase 3 trial enrolled 303 female participants with breast cancer in Australia and has been completed. The trial was randomized but not double-blinded.

Is Alendronate the same as a bisphosphonate?

Yes, Alendronate is a bisphosphonate. It is being evaluated in combination with anastrozole in a bone maintenance algorithm for breast cancer patients. The drug is a small molecule and is being studied for its potential role in managing bone health in this oncology population.