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Atezolizumab

Phase 1

Metastatic Breast Cancer | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 12, 2026

Target and mechanism

Molecular targetCD274
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,132

FDA Designations

No designations recorded

Clinical trial landscape

Atezolizumab · 1 trial · 1 indication

Phase 1 1
NCT03424005A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast CancerMetastatic Breast Cancer
RECRUITING1,132 Analytics
PHASE1RECRUITING
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)

Secondary Endpoints

Progression Free Survival (PFS)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 12 years) as determined by the investigator according to RECIST v1.1
Disease Control Rate (DCR)
Baseline through end of study (up to approximately 12 years)
Overall Survival (OS)
Randomization to death from any cause, through the end of study (up to approximately 12 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Atezolizumab + Nab-PaclitaxelACTIVE_COMPARATOR1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
Atezolizumab + Nab-Paclitaxel + TocilizumabEXPERIMENTAL1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete.
Atezolizumab + Sacituzumab GovitecanEXPERIMENTAL1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
CapecitabineACTIVE_COMPARATOR2L CIT-naïve participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Participants who progressed on treatment may have the option of receiving atezolizumab along with chemotherapy (chemo) during stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.
Atezolizumab + IpatasertibEXPERIMENTAL2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.
Atezolizumab + SGN-LIV1AEXPERIMENTAL2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Patients who experience loss of clinical benefit as determined by the investigator or unacceptable toxicity related to SGN-LIV1A will be given the option of receiving Atezolizumab + chemo during Stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.
Atezolizumab + Selicrelumab + BevacizumabEXPERIMENTAL2L-CIT-naïve participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.
Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)EXPERIMENTAL2L CIT-naïve participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naïve participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemo (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete.
Inavolisib (Dose #2) + Abemaciclib + FulvestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Ribociclib (Dose #1) + FulvestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Ribociclib (Dose #1) + LetrozoleEXPERIMENTALHR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Ribociclib (Dose #2) + FulvestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Ribociclib (Dose #2) + LetrozoleEXPERIMENTALHR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Abemaciclib + LetrozoleEXPERIMENTALHR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #1) + Trastuzumab DeruxtecanEXPERIMENTALHER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed.
Inavolisib (Dose #2) + Trastuzumab DeruxtecanEXPERIMENTALHER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed.
Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± PalbociclibEXPERIMENTALParticipants with locally advanced or metastatic, HR+, HER2- participants will receive empagliflozin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Metformin + Inavolisib (Dose #2) + Fulvestrant ± PalbociclibEXPERIMENTALParticipants with locally advanced or metastatic, HR+, HER2- participants will receive metformin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Atirmociclib (Atirmo) + FulvestrantEXPERIMENTALParticipants will receive inavolisib plus atirmociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #1) + Abemaciclib + LetrozoleEXPERIMENTALHR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #1) + Abemaciclib + GiredestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Abemaciclib + GiredestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Inavolisib (Dose #2) + Ribociclib (Dose #1) + GiredestrantEXPERIMENTALHR+ participants will receive treatment with inavolisib plus ribociclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Interventions

NameTypeDescription
CapecitabineDRUGCapecitabine will be administered 1250 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day cycle.
AtezolizumabDRUGFor Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, or Atezolizumab + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle. For Atezolizumab + Nab-Paclitaxel, Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Ipatasertib, or Atezolizumab + Nab-Paclitaxel + Tocilizumab arms: atezolizumab will be administered IV, 840 mg on Days 1 and 15 of each 28-day cycle.
IpatasertibDRUGIpatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle.
SGN-LIV1ADRUGSGN-LIV1A will be administered IV, 2.5 milligrams per kilogram (mg/kg) (maximum calculated dose 250 mg), on Day 1 of each 21-day cycle.
BevacizumabDRUGBevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle.
Chemotherapy (Gemcitabine + Carboplatin or Eribulin)DRUGGemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, on Days 1 and 8 of each 21-day cycle. Or Eribulin will be administered IV, 1.4 mg/m\^2 on Days 1 and 8 of each 21-day cycle.
SelicrelumabDRUGSelicrelumab will be administered by subcutaneous (SC) injection, at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (Cycle = 28 days).
TocilizumabDRUGTocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle.
Nab-PaclitaxelDRUGNab-Paclitaxel will be administered IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
Sacituzumab GovitecanDRUGSacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.
AbemaciclibDRUGAbemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle.
FulvestrantDRUGFor Inavolisib + Abemaciclib + Fulvestrant, Inavolisib + Ribociclib (Dose #1) + Fulvestrant, Inavolisib + Ribociclib (Dose #2) + Fulvestrant, or Inavolisib + Atirmociclib + Fulvestrant arms: Fulvestrant 500 mg, administered as an IM injection on Days 1 and 15 of Cycle 1, followed by Day 1 of each 28-day cycle thereafter. For Empa + Inavolisib + Fulvestrant ± Palbociclib, or Metformin + Inavolisib + Fulvestrant ± Palbociclib arms: Fulvestrant 500 mg, administered as an IM injection on Day 1 and as per local prescribing guidelines thereafter.
Ribociclib (Dose #1)DRUGRibociclib tablets will be administered by mouth once daily.
Inavolisib (Dose #1)DRUGInavolisib tablets will be administered by mouth once daily.
Trastuzumab DeruxtecanDRUGTrastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle.
Ribociclib (Dose #2)DRUGRibociclib tablets will be administered by mouth once daily.
LetrozoleDRUGLetrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each 28-day cycle.
Inavolisib (Dose #2)DRUGInavolisib tablets will be administered by mouth OD.
EmpagliflozinDRUGEmpagliflozin, administered orally, once daily (QD)
PalbociclibDRUGFor Empagliflozin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1 followed by 125 mg on Days 1-21 of each cycle. For Metformin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1, followed by 125 mg on Days 1-21 of each cycle (Cycle=28 days).
MetforminDRUGMetf 1000 mg administered orally QD.
AtirmociclibDRUGAtirmociclib administered orally, BID on Days 1-28 for each 28-day cycle.
GiredestrantDRUGGiredestrant 30 mg will be administered by mouth once daily, on Days 1-28 of each 28-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort): * Age \>/= 18 years at the time of signing Informed Consent Form * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Abl...

Countries:United StatesAustraliaFranceGermanyIsraelSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials (matched to "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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Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT03424005lastUpdatePostDate: changed
LOWAug 12, 2026NCT03424005lastUpdatePostDate: changed
MEDIUMAug 1, 2026NCT03424005Enrollment: 792 → 1132
MEDIUMAug 1, 2026NCT03424005Enrollment: 792 → 1132
MEDIUMAug 1, 2026NCT03424005Enrollment: 792 → 1132

Frequently asked questions about Atezolizumab

What is Atezolizumab used for in metastatic breast cancer?

Atezolizumab is an investigational antibody being studied for the treatment of metastatic breast cancer. It is currently in Phase 1 clinical development, with an active trial evaluating its efficacy and safety in combination with other treatments for patients with metastatic or locally advanced breast cancer.

What does Atezolizumab target?

Atezolizumab is a monoclonal antibody, classified as a -mab antibody. It is being studied in oncology for metastatic breast cancer, where it is evaluated in combination with other treatment regimens to assess its therapeutic potential.

Who is developing Atezolizumab?

Atezolizumab is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's efficacy and safety in patients with metastatic breast cancer.

What phase is Atezolizumab in?

Atezolizumab is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in an active clinical trial for metastatic breast cancer. The trial is currently recruiting participants.

What clinical trials is Atezolizumab in?

Atezolizumab is being evaluated in clinical trial NCT03424005, titled "A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer." This Phase 1 trial is actively recruiting and has an enrollment of 1,132 participants across multiple countries.

Is Atezolizumab the same as other cancer drugs?

Atezolizumab is a distinct monoclonal antibody being developed by Gilead Sciences for metastatic breast cancer. It is currently in Phase 1 trials, and no alternative names have been established for this investigational drug.