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Adriamycine

Phase 2

Breast Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 6, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Adriamycine · 1 trial · 1 indication

Phase 2 1
NCT00128856Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer PatientsBreast Cancer
COMPLETED46 Analytics
PHASE2COMPLETED
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Pathological complete response (pCR) rate
Up to week 15

pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.

Secondary Endpoints

Overall response rate (ORR)
Up to week 12
Conservative surgery rate
Up to week 15
The Number of Participants Who Experienced Adverse Events (AE)
Through study treatment up to surgery
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Gemcitabine + Adriamycine + PaclitaxelEXPERIMENTALNeoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.

Interventions

NameTypeDescription
GemcitabineDRUG -
AdriamycineDRUG -
PaclitaxelDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy. * Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible. * Patients cannot have received previous treatment with chemotherapy, ho...

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 Adriamycine

What is Adriamycine used for?

Adriamycine is used for breast cancer. It is being studied as part of a neoadjuvant treatment regimen for breast cancer patients. The drug is a small molecule oncology therapy currently in clinical development.

Who makes Adriamycine?

Adriamycine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this drug for the treatment of breast cancer.

What phase is Adriamycine in?

Adriamycine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in breast cancer patients.

What clinical trials is Adriamycine in?

Adriamycine has one completed clinical trial, NCT00128856, titled 'Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients'. This Phase 2 trial enrolled 46 female patients in Spain and was not randomized or double-blinded.

How does Adriamycine work?

Adriamycine is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information, so its exact mechanism of action is not detailed here.