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Herceptin

Phase 2

Breast Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 18, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

Herceptin · 1 trial · 1 indication

Phase 2 1
NCT00136539Neoadjuvant Therapy With Herceptin and Taxol for Breast CancerBreast Cancer
COMPLETED41 Analytics
PHASE2COMPLETED
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery

Secondary Endpoints

To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
HerceptinDRUGGiven intravenously once weekly for 12 weeks prior to surgery.
TaxolDRUGGiven intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
AdriamycinDRUGGiven every three weeks for 12 weeks after surgery.
CytoxanDRUGGiven every three weeks for 12 weeks after surgery.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients must have Stage II or III histologically diagnosed breast cancer * Primary invasive breast cancers that overexpress the HER2/neu oncogene * Age older than 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 * White blood cell (WBC) \> 4000/...

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 Herceptin

What is Herceptin used for in breast cancer?

Herceptin is used for the treatment of breast cancer. It is being studied as a neoadjuvant therapy, meaning it is given before the main treatment, in combination with Taxol for breast cancer patients. The drug is currently in Phase 2 clinical development for this indication.

Who makes Herceptin?

Herceptin is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with breast cancer.

What phase is Herceptin in?

Herceptin is in Phase 2 clinical development for breast cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a clinical trial to assess its effects when used as neoadjuvant therapy.

What clinical trials is Herceptin in?

Herceptin is being studied in one clinical trial with the identifier NCT00136539. This Phase 2 trial, titled 'Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer,' has been completed and enrolled 41 participants in the United States. The trial was not randomized or double-blind.

Is Herceptin FDA approved?

Herceptin is not FDA approved for breast cancer. It is an investigational drug currently in Phase 2 clinical development. The completed clinical trial, NCT00136539, evaluated Herceptin as neoadjuvant therapy, but the drug has not yet received regulatory approval.