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TAC

Phase 3

Breast Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Feb 4, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2,014

FDA Designations

No designations recorded

Clinical trial landscape

TAC · 1 trial · 1 indication

Phase 3 1
NCT00544765Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast CancerBreast Cancer
COMPLETED2,014 Analytics
PHASE3COMPLETED
Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of pCR rates
2010

To determine the iRR rate of 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC-NX) as a salvage treatment

Secondary Endpoints

To determine the toxicity and compliance to each arm
2010
To determine the breast conservation rate in each arm
2010
To determine the disease-free and overall survival in each arm
2010
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
resp: 4xTACEXPERIMENTALPatients sufficiently responding (iPR, iCR) will recieve 4 further cycles of TAC
resp: 6xTACEXPERIMENTALPatients sufficiently responding (iPR, iCR) will recieve 6 further cycles of TAC
nonResp: 4xTACEXPERIMENTALPatients non-sufficiently responding (iNC) will recieve 4 further cycles of TAC
nonResp: 4xNXEXPERIMENTALPatients non-sufficiently responding (iNC) will recieve 4 further cycles of NX

Interventions

NameTypeDescription
TACDRUGDocetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
NXDRUGVinorelbine 25 mg/m² as a \< 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. * Complete baseline documentation sent to SKM CRS. * Unilateral or bilateral primary carcinoma of the breast, confirmed hist...

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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 TAC

What is TAC used for in breast cancer?

TAC is a combination chemotherapy regimen used in breast cancer. It is being studied as preoperative treatment for patients with locally advanced or operable primary breast cancer. The regimen combines docetaxel, doxorubicin, and cyclophosphamide. It is currently in Phase 3 clinical development and is considered investigational.

What does TAC target?

TAC is a combination of three chemotherapy drugs: docetaxel, doxorubicin, and cyclophosphamide. These agents target rapidly dividing cancer cells by interfering with microtubule function, DNA replication, and cell division. The regimen is used in the treatment of breast cancer.

Who makes TAC?

TAC is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The company is conducting clinical trials to evaluate the regimen in breast cancer patients.

What phase is TAC in?

TAC is in Phase 3 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 2014 female patients aged 18 years and older with breast cancer.

What clinical trials is TAC in?

TAC has one completed Phase 3 clinical trial, identified as NCT00544765. The trial compared docetaxel, doxorubicin, and cyclophosphamide versus vinorelbine and capecitabine in patients with locally advanced or operable primary breast cancer. The study enrolled 2014 participants and was completed.

Is TAC the same as docetaxel, doxorubicin, and cyclophosphamide?

Yes, TAC refers to the combination of docetaxel, doxorubicin, and cyclophosphamide. These three drugs are used together as a chemotherapy regimen for breast cancer. The regimen was evaluated in a Phase 3 clinical trial for preoperative treatment of breast cancer.