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Epidoxorubicin

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 9, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Epidoxorubicin · 1 trial · 1 indication

Phase 2 1
NCT00559845A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast CancerBreast Cancer
COMPLETED56 Analytics
PHASE2COMPLETED
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Up to 7.5 years

Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.

Secondary Endpoints

Objective Response Rate
Up to 7.5 years
Percentage of Participants With Breast-Conserving Surgery
Up to 7.5 years
Percentage of Participants With Disease-Free Interval
Months 12, 24, 36, 48, and 60
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BevacizumabEXPERIMENTALParticipants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.

Interventions

NameTypeDescription
5-fluorouracilDRUG600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
EpidoxorubicinDRUG90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
CyclophosphamideDRUG600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
PaclitaxelDRUGPaclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
BevacizumabBIOLOGICALBevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * female participants, \>=18 years of age; * stage III, or inflammatory breast cancer; * estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative; * normal left ventricular ejection fraction (LVEF). Excl...

Countries:Italy
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Competitive Landscape -Breast Cancer 399 trials

Top 20 of 91 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN46PHASE3Fulvestrant, 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 CorpBCTX1PHASE3SV-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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