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Aromatase Inhibitor

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Jan 9, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Aromatase Inhibitor · 1 trial · 1 indication

Phase 2 1
NCT00773695A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast CancerBreast Cancer
COMPLETED150 Analytics
PHASE2COMPLETED
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)
Baseline up to end of study treatment (approximately 24 weeks)

Secondary Endpoints

Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment
Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Type of Surgery
At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Axillary Lymph Node Dissection Performed
At Surgery (Between Weeks 24 and 25)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ChemotherapyACTIVE_COMPARATORParticipants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.
Chemotherapy and BevacizumabEXPERIMENTALParticipants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks.
Endocrine TherapyACTIVE_COMPARATORParticipants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.
Endocrine Therapy and BevacizumabEXPERIMENTALParticipants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.

Interventions

NameTypeDescription
Aromatase InhibitorDRUGParticipants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.
BevacizumabDRUGBevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.
EpirubicineDRUGParticipants will receive epirubicine at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.
5-Fluorouracil (5FU)DRUGParticipants will receive 5FU at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.
CyclophosphamideDRUGParticipants will receive cyclophosphamide at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.
PaclitaxelDRUGParticipants will receive paclitaxel at a dose of 80 mg/m\^2 as IV infusion every week for 12 weeks.
DocetaxelDRUGParticipants will receive docetaxel at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (\>=) 2.5 centimeters (cm) in size * Eastern Cooperative Oncology Group (ECOG)/world health organization ...

Countries:Norway
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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 Aromatase Inhibitor

What is Aromatase Inhibitor used for?

Aromatase Inhibitor is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in combination with other treatment regimens for patients with primary HER2 negative breast cancer.

Who makes Aromatase Inhibitor?

Aromatase Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug for the treatment of breast cancer.

What phase is Aromatase Inhibitor in?

Aromatase Inhibitor is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Aromatase Inhibitor in?

Aromatase Inhibitor has been studied in one completed Phase 2 clinical trial, identified as NCT00773695. This trial evaluated the drug in combination with neoadjuvant treatment regimens in participants with primary HER2 negative breast cancer. The trial enrolled 150 participants in Norway.

Is Aromatase Inhibitor the same as Avastin?

Aromatase Inhibitor is not the same as Avastin. The clinical trial NCT00773695 studied Aromatase Inhibitor in combination with bevacizumab (Avastin) and other neoadjuvant treatment regimens for HER2 negative breast cancer. Aromatase Inhibitor is a distinct investigational drug being developed by Roche.