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Epirubicin

Phase 2

Breast Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Nov 23, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment233

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin · 2 trials · 1 indication

Phase 2 2
NCT00193206Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast CancerBreast Cancer
COMPLETED123 Analytics
NCT00193050Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast CancerBreast Cancer
COMPLETED110 Analytics
PHASE2COMPLETED
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Breast CancerUnlock trial analytics
PHASE2COMPLETED
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Pathologic Complete Response
18 months

For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Pathologic Complete Response (pCR)
18 Months

For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Secondary Endpoints

Clinical Response Rates
18 months
Time to Disease Progression
36 months
Rates of Breast Preservation
18 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
InterventionEXPERIMENTALPatients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.

Interventions

NameTypeDescription
GemcitabineDRUGGemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
EpirubicinDRUGEpirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Albumin-bound PaclitaxelDRUGABI-007 175 mg/m2 D1 q 14 days x 6 cycles
DocetaxelDRUGDocetaxel
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Locally advanced/inflammatory adenocarcinoma of the breast * 18 years of age or older * Normal heart function * Able to perform activities of daily living with minimal assistance * No prior chemotherapy for b...

Countries:United States
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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, specifically in locally advanced or inflammatory breast cancer. It is currently in Phase 2 clinical development and is being investigated as part of combination chemotherapy regimens.

Who makes Epirubicin?

Epirubicin is being developed by Eli Lilly and Company, which trades under the ticker symbol LLY on the stock exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with breast cancer.

What phase is Epirubicin in?

Epirubicin is currently in Phase 2 clinical development for breast cancer. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total of 233 patients enrolled across both studies.

What clinical trials is Epirubicin in?

Epirubicin has been studied in two completed Phase 2 clinical trials. NCT00193050 evaluated weekly gemcitabine, epirubicin, and docetaxel in locally advanced or inflammatory breast cancer with 110 female participants. NCT00193206 assessed neo-adjuvant gemcitabine, epirubicin, and ABI-007 (GEA) in the same patient population with 123 female participants in the United States.

How does Epirubicin work?

Epirubicin is a small molecule drug used in oncology. It works by interfering with the replication of cancer cells, ultimately leading to cell death. This mechanism makes it effective in treating breast cancer when used in combination with other chemotherapeutic agents.