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Epirubicin

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,384

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin · 1 trial · 1 indication

Phase 3 1
NCT00129935EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast CancerBreast Cancer
COMPLETED1,384 Analytics
PHASE3COMPLETED
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Disease-free Survival (DFS) Event
5 years

A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.

Secondary Endpoints

Number of Participants With Overall Survival (OS) Event
Up to 5 years
The Number of Participants Who Experienced Adverse Events (AE)
5 years
Quality of Life Questionnaire: Number of Participants With Hair Loss
Up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: EC-TACTIVE_COMPARATOREpirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Arm B: ET-XEXPERIMENTALEpirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.

Interventions

NameTypeDescription
DocetaxelDRUG -
CapecitabineDRUG -
EpirubicinDRUG -
CyclophosphamideDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: * Written informed consent. * Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days. * Surgery must consist of mastectomy or conservative surg...

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 an oncology small molecule being studied for use in breast cancer. It is currently in Phase 3 clinical development as an adjuvant chemotherapy for patients with node positive operable breast cancer. The drug is being developed by Sanofi.

Who makes Epirubicin?

Epirubicin is being developed by Sanofi, a company traded on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical trials for the treatment of breast cancer.

What phase is Epirubicin in?

Epirubicin is in Phase 3 clinical development. It is an investigational drug being studied for breast cancer and has not yet been approved by regulatory authorities. A Phase 3 trial for the drug has been completed.

What clinical trials is Epirubicin in?

Epirubicin has been studied in a Phase 3 clinical trial with the identifier NCT00129935. This trial, titled "EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer," enrolled 1,384 female patients aged 18 years and older in Spain. The trial has been completed.

Is Epirubicin the same as other breast cancer drugs?

Epirubicin is a distinct drug being studied for breast cancer. It is being evaluated in a clinical trial that compares different chemotherapy regimens, including epirubicin combined with other agents, for the adjuvant treatment of node positive operable breast cancer.