Recent Updates
Recently added Catalysts

5-fluorouracil

Phase 2

Breast Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Feb 26, 2010

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

5-fluorouracil · 1 trial · 1 indication

Phase 2 1
NCT00124111A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast CancerBreast Cancer
COMPLETED- Analytics
PHASE2COMPLETED
A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the relative dose intensity (RDI) of IV CMF Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with Stage I-III breast cancer.

Secondary Endpoints

Incidence of febrile neutropenic events over all cycles
Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
Safety profile over all cycles
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Interventions

NameTypeDescription
pegfilgrastimDRUG -
cyclophosphamideDRUG -
methotrexateDRUG -
5-fluorouracilDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Histologically confirmed breast cancer Stage I, II or III - Candidate for IV CMF chemotherapy (every 4 weeks) for a total of 6 cycles - Chemotherapy naïve (prior treatment with hormone therapy or with anti-HER2 monoclonal antibody therapy is permitted as long as treatment has b...

Unlock Eligibility Criteria

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
Unlock Competitive Intelligence

Frequently asked questions about 5-fluorouracil

What is 5-fluorouracil used for in breast cancer?

5-fluorouracil is a small molecule being studied for use in breast cancer. It is currently in Phase 2 clinical development as part of a combination regimen with cyclophosphamide and methotrexate, known as CMF, along with pegfilgrastim. The drug is being investigated for its potential role in treating patients with breast cancer.

Who makes 5-fluorouracil?

5-fluorouracil is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical research on this drug for the treatment of breast cancer.

What phase is 5-fluorouracil in?

5-fluorouracil 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 Phase 2 trial has been completed, and the drug remains under investigation for this indication.

What clinical trials is 5-fluorouracil in?

5-fluorouracil is associated with clinical trial NCT00124111, titled "A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer." This Phase 2 trial has been completed and enrolled adult patients with breast cancer.

How does 5-fluorouracil work?

5-fluorouracil is a small molecule chemotherapeutic agent. It is used in combination with cyclophosphamide and methotrexate as part of the CMF regimen for breast cancer. The drug is being studied for its ability to treat this disease, though the specific molecular target has not been disclosed.

Is 5-fluorouracil the same as CMF?

5-fluorouracil is one component of the CMF regimen, which also includes cyclophosphamide and methotrexate. The clinical trial NCT00124111 studies the combination of these three drugs along with pegfilgrastim in patients with breast cancer. 5-fluorouracil itself is not synonymous with the full CMF regimen.