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Taxane-based chemotherapy

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: May 25, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment2,296

FDA Designations

No designations recorded

Clinical trial landscape

Taxane-based chemotherapy · 1 trial · 1 indication

Phase 3 1
NCT00448591A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.Breast Cancer
COMPLETED2,296 Analytics
PHASE3COMPLETED
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)
Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.

Secondary Endpoints

Percentage of Participants With Disease Progression
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Time to Progression (TTP)
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Percentage of Participants With Recorded Death
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
bevacizumab [Avastin]DRUG10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
Taxane-based chemotherapyDRUGAs prescribed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites457

Inclusion Criteria: * patients, \>=18 years of age; * HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting; * candidates for chemotherapy. Exclusion Criteria: * previou...

Countries:ArgentinaAustraliaAustriaBrazilBulgariaCanadaChinaColombiaCzechiaEcuadorEgyptEstoniaFinlandFranceGermanyHong KongHungaryIsraelItalyLatviaLebanonLithuaniaMexicoMoroccoNetherlandsPolandPortugalRussiaSaudi ArabiaSlovakiaSloveniaSpainSwedenSwitzerlandTurkey (Türkiye)United Kingdom
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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 Taxane-based chemotherapy

What is Taxane-based chemotherapy used for in breast cancer?

Taxane-based chemotherapy is used for the treatment of locally recurrent or metastatic breast cancer. It was studied in a Phase 3 clinical trial in combination with Avastin (bevacizumab) for this patient population.

Who makes Taxane-based chemotherapy?

Taxane-based chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 3 study of this therapy in combination with bevacizumab for breast cancer.

What phase is Taxane-based chemotherapy in?

Taxane-based chemotherapy is in Phase 3 clinical development. A Phase 3 trial, NCT00448591, has been completed, and the drug remains investigational for the treatment of breast cancer.

What clinical trials is Taxane-based chemotherapy in?

Taxane-based chemotherapy has been studied in one completed Phase 3 clinical trial, NCT00448591, titled 'A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.' The trial enrolled 2,296 participants.

Is Taxane-based chemotherapy FDA approved?

Taxane-based chemotherapy is investigational and still in clinical development. It has not been reported as FDA approved, and its Phase 3 trial for breast cancer has been completed but no approval status has been indicated.