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Zoledronic Acid; Letrozole

Phase 2

Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Mar 1, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

Zoledronic Acid; Letrozole · 1 trial · 1 indication

Phase 2 1
NCT00247650Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant TherapyBreast Cancer
COMPLETED190 Analytics
PHASE2COMPLETED
Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical response at 24 weeks

Secondary Endpoints

Clinical response at 16 weeks
Clinical benefit at 16 weeks
Clinical benefit at 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Zoledronic Acid; LetrozoleDRUG -
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Eligibility Criteria

Age Range65 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites10

Inclusion Criteria * Postmenopausal women * Newly diagnosed with non metastatic breast cancer * Candidate for mastectomy or breast-conserving surgery Exclusion Criteria * Patients with invasive tumors * Patients receiving anti-cancer treatment * Patients who have undergone surgery Other protocol...

Countries:Canada
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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 Zoledronic Acid; Letrozole

What is Zoledronic Acid; Letrozole used for in breast cancer?

Zoledronic Acid; Letrozole is a combination of two small molecule drugs being studied as neoadjuvant therapy for early breast cancer in women aged 65 years and older. The combination is intended to be given before primary treatment to assess its effects on the tumor.

Who makes Zoledronic Acid; Letrozole?

Zoledronic Acid; Letrozole is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this combination for the treatment of breast cancer.

What phase is Zoledronic Acid; Letrozole in?

Zoledronic Acid; Letrozole is in Phase 2 clinical development. It is an investigational combination and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is Zoledronic Acid; Letrozole in?

Zoledronic Acid; Letrozole has been studied in one completed Phase 2 trial, NCT00247650, which compared letrozole alone to letrozole with zoledronic acid in early breast cancer as neoadjuvant therapy. The trial enrolled 190 women aged 65 years and older in Canada.

Is Zoledronic Acid; Letrozole the same as letrozole alone?

No, Zoledronic Acid; Letrozole is a combination of two drugs, zoledronic acid and letrozole, whereas letrozole alone is a single agent. The clinical trial NCT00247650 was designed to compare the combination against letrozole monotherapy in early breast cancer.