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Lapatinib

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Feb 27, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment608

FDA Designations

No designations recorded

Clinical trial landscape

Lapatinib · 1 trial · 1 indication

Phase 3 1
NCT03523585DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]Breast Cancer
COMPLETED608 Analytics
PHASE3COMPLETED
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Baseline up to 46 months postdose

Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

Secondary Endpoints

Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Baseline up to 46 months postdose
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Baseline up to 46 months postdose
Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Baseline up to 46 months postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Trastuzumab deruxtecan (DS-8201a)EXPERIMENTALHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Trastuzumab+capecitabineACTIVE_COMPARATORHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
Lapatinib+capecitabineACTIVE_COMPARATORHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Interventions

NameTypeDescription
Trastuzumab deruxtecanDRUGDS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
CapecitabineDRUGInvestigator's choice Standard of Care when combined with trastuzumab or lapatinib
LapatinibDRUGInvestigator's choice Standard of Care when combined with capecitabine
TrastuzumabDRUGInvestigator's choice Standard of Care when combined with capecitabine
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites227

Inclusion Criteria: * Is the age of majority in their country * Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guide...

Countries:United StatesAustraliaBelgiumBrazilCzechiaFranceGermanyGreeceIsraelItalyJapanSouth KoreaSpainTurkey (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 Lapatinib

What is Lapatinib used for in breast cancer?

Lapatinib is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in a Phase 3 clinical trial for patients with HER2-positive breast cancer that cannot be surgically removed or has spread. The drug is being developed by AstraZeneca PLC.

What does Lapatinib target?

Lapatinib targets the HER2 receptor, which is a protein that promotes the growth of cancer cells. By inhibiting HER2, Lapatinib aims to slow or stop the growth of HER2-positive breast cancer. This targeted approach is being studied in a Phase 3 clinical trial for patients with advanced breast cancer.

Who makes Lapatinib?

Lapatinib is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Lapatinib in patients with breast cancer.

What phase is Lapatinib in?

Lapatinib is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess its efficacy and safety in patients with HER2-positive breast cancer that is advanced or metastatic.

What clinical trials is Lapatinib in?

Lapatinib is being studied in a Phase 3 clinical trial with the identifier NCT03523585. This trial, titled 'DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]', has been completed and enrolled 608 participants across multiple countries including the United States, Australia, and Japan.

Is Lapatinib the same as DS-8201a?

Lapatinib is not the same as DS-8201a. The clinical trial NCT03523585 is evaluating DS-8201a, not Lapatinib. Lapatinib is a separate investigational drug being developed by AstraZeneca for breast cancer. The trial information provided does not indicate that Lapatinib has any alternative names.