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Nab-Paclitaxel

Phase 3

Advanced or Metastatic Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 4, 2026

Target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment866

FDA Designations

No designations recorded

Clinical trial landscape

Nab-Paclitaxel · 1 trial · 1 indication

Phase 3 1
NCT04494425Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast CancerAdvanced or Metastatic Breast Cancer
ACTIVE NOT_RECRUITING866 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Advanced or Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.

Secondary Endpoints

Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Overall Survival (OS) in the Intent-to-Treat Population
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Trastuzumab deruxtecanEXPERIMENTALTrastuzumab deruxtecan (T-DXd; DS-8201a) arm
Standard of CareACTIVE_COMPARATORInvestigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Interventions

NameTypeDescription
Trastuzumab deruxtecanDRUGTrastuzumab deruxtecan by intravenous infusion
CapecitabineDRUGInvestigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
PaclitaxelDRUGInvestigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
Nab-PaclitaxelDRUGInvestigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
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Eligibility Criteria

Age Range18 Years to 105 Years
SexALL
Healthy VolunteersNo
Study Sites293

Key Inclusion Criteria: * Patients must be ≥18 years of age * Pathologically documented breast cancer that: 1. is advanced or metastatic 2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaDenmarkFranceGermanyHungaryIndiaIsraelItalyJapanMexicoNetherlandsPolandPortugalRussiaSaudi ArabiaSingaporeSouth KoreaSpainSwedenTaiwanUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials (matched to "Advanced or Metastatic Breast Cancer")

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 Nab-Paclitaxel

What is Nab-Paclitaxel used for?

Nab-Paclitaxel is being studied for use in advanced or metastatic breast cancer and small cell lung carcinoma. It is an oncology small molecule being evaluated in combination with other agents as part of clinical trials for these indications.

Who is developing Nab-Paclitaxel?

Nab-Paclitaxel is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug in oncology indications.

What phase is Nab-Paclitaxel in?

Nab-Paclitaxel is in Phase 3 clinical development. It is an investigational drug being studied in active clinical trials for advanced or metastatic breast cancer and is not yet approved by regulatory authorities.

What clinical trials is Nab-Paclitaxel in?

Nab-Paclitaxel is part of the Phase 3 trial NCT04494425, which studies trastuzumab deruxtecan versus investigator's choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer. This trial has enrolled 866 participants across multiple countries.

Is Nab-Paclitaxel the same as Nab-paclitaxel+carboplatin?

Nab-Paclitaxel is also known as Nab-paclitaxel+carboplatin, which refers to the combination regimen being studied. The drug is being evaluated in combination with carboplatin in clinical trials for certain cancers.