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Epirubicin

Phase 2

Breast Cancer | Small molecule | Oncology |GSK plc|Last Updated: Mar 31, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin · 1 trial · 1 indication

Phase 2 1
NCT00841828Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ PatientsBreast Cancer
COMPLETED102 Analytics
PHASE2COMPLETED
Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).
Up to 16 weeks

Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.

Secondary Endpoints

Overall Clinical Response Rate (ORR)
Up to 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ExperimentalEXPERIMENTALEpirubicin + Cyclophosphamide -\> Docetaxel + Lapatinib
ControlACTIVE_COMPARATOREpirubicin + Cyclophosphamide -\> Docetaxel + Trastuzumab

Interventions

NameTypeDescription
EpirubicinDRUG -
CyclophosphamideDRUG -
DocetaxelDRUG -
LapatinibDRUG -
TrastuzumabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Signature of the written informed consent. 2. Histological documentation of breast cancer. 3. Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer. 4. HER2-positive b...

Countries:Spain
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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 Epirubicin

What is Epirubicin used for in breast cancer?

Epirubicin is a small molecule oncology drug being studied for the treatment of breast cancer. It is currently in Phase 2 clinical development as an investigational therapy. In the completed clinical trial, it was evaluated in patients with HER2-positive breast cancer as part of a neoadjuvant treatment regimen.

Who makes Epirubicin?

Epirubicin is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating breast cancer.

What phase is Epirubicin in?

Epirubicin is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the drug is not currently in any active trials.

What clinical trials is Epirubicin in?

Epirubicin has been studied in one completed Phase 2 clinical trial with the identifier NCT00841828. The trial, titled 'Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients', enrolled 102 female patients with breast cancer in Spain. The trial was randomized and active-controlled, and it included biomarker selection.

Is Epirubicin the same as any other drug?

Epirubicin is not known to have any alternative names. It is a distinct drug entity being developed by GSK plc for the treatment of breast cancer. Its mechanism of action has not been specified in the available information.