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Taxotere

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Dec 21, 2012

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,611

FDA Designations

No designations recorded

Clinical trial landscape

Taxotere · 1 trial · 1 indication

Phase 3 1
NCT00089479A Study of Xeloda (Capecitabine) in Women With High-Risk Breast CancerBreast Cancer
COMPLETED2,611 Analytics
PHASE3COMPLETED
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Free Survival [Number of Events]
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Number of patients with/without recurrence of breast cancer, or death due to any cause.

Disease Free Survival [Time to Event]
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Secondary Endpoints

Overall Survival [Number of Events]
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
capecitabine [Xeloda]DRUG825mg/m2 po bid on days 1-14 of each 3 week cycle
TaxotereDRUG75mg/m2 iv on day 1 of each 3 week cycle
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * female patients 18-70 years of age; * adenocarcinoma of the breast; * previous invasive breast cancer if diagnosed \>5 years before entering study; * no evidence of metastatic disease. Exclusion Criteria: * history of severe hypersensitivity reaction to Taxotere; * previous ...

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 Taxotere

What is Taxotere used for in breast cancer?

Taxotere is a small molecule oncology drug being studied for the treatment of breast cancer. It is currently in Phase 3 clinical development for this indication. The drug is being evaluated in women with high-risk breast cancer.

Who makes Taxotere?

Taxotere is developed by Roche Holding AG, a company traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's use in breast cancer treatment.

What phase is Taxotere in?

Taxotere is in Phase 3 clinical development for breast cancer. It is an investigational drug and has not been approved for this use. One Phase 3 trial has been completed to assess its effects in patients with high-risk breast cancer.

What clinical trials is Taxotere in?

Taxotere has been studied in a completed Phase 3 clinical trial with the identifier NCT00089479. This trial enrolled 2,611 women with high-risk breast cancer and was conducted in the United States. The study was active-controlled, meaning patients received an alternative treatment for comparison.

Is Taxotere the same as capecitabine?

Taxotere is not the same as capecitabine. In the clinical trial NCT00089479, Taxotere was evaluated in combination with capecitabine, which is also known as Xeloda. The study compared this combination against a control treatment in women with high-risk breast cancer.