Advanced Breast Cancer

Oncology
22
Pipeline Programs
18
Companies
23
Clinical Trials
5 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
4
4
0
5
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

ADC
360%
Small Molecule
120%
Monoclonal Antibody
120%
+ 24 programs with unclassified modality

On Market (2)

Approved therapies currently available

AstraZeneca
FASLODEXApproved
fulvestrant
AstraZeneca
Estrogen Receptor Antagonist [EPC]intramuscular2002
U
FULVESTRANTApproved
fulvestrant
Unknown Company
Estrogen Receptor Antagonist [EPC]intramuscular2019

Competitive Landscape

18 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
4 programs
2
1
1
FulvestrantPhase 31 trial
CamizestrantPhase 21 trial
Goserelin acetatePhase 21 trial
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Active Trials
NCT07427394Not Yet Recruiting24Est. Dec 2027
NCT00322348Completed98Est. Nov 2009
NCT00635713Completed588Est. Sep 2004
Novartis
NovartisBASEL, Switzerland
2 programs
1
TrastuzumabPhase 3Monoclonal Antibody5 trials
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Active Trials
NCT07136428Not Yet Recruiting42Est. Nov 2032
NCT05722886Recruiting825Est. Oct 2029
NCT05063786Active Not Recruiting27Est. Jun 2026
+2 more trials
Pierre Fabre
Pierre FabreFrance - Aignan
2 programs
1
Vinflunine+GemcitabinePhase 31 trial
Vinorelbine Tartrate OralN/A1 trial
Active Trials
NCT06500494Recruiting368Est. Feb 2028
NCT02054338Terminated1,004Est. Feb 2015
Stemline Therapeutics
2 programs
1
1
EverolimusPhase 31 trial
MEN2312Phase 11 trial
Active Trials
NCT06638307Recruiting240Est. Oct 2026
NCT06382948Recruiting240Est. Apr 2028
Arvinas
ArvinasCT - New Haven
1 program
1
ARV-471Phase 3
DS
Daiichi SankyoChina - Shanghai
2 programs
1
Trastuzumab deruxtecanPhase 2ADC1 trial
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Active Trials
NCT04420598Completed41Est. Apr 2023
BioMarin Pharmaceutical
1 program
1
Talazoparib TosylatePhase 2
GS
Gilead SciencesFOSTER CITY, CA
3 programs
1
Debio 0123 and Sacituzumab govitecanPhase 1/2ADC1 trial
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A1 trial
Active Trials
NCT03577197Recruiting7,000Est. Dec 2027
NCT06612203Active Not Recruiting76Est. Oct 2027
CT
2 programs
1
1
TQB3909 tabletsPhase 1/21 trial
TQB3616Phase 11 trial
Active Trials
NCT03850873UnknownEst. Sep 2021
NCT05775575UnknownEst. Dec 2023
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
2 programs
1
1
QLC1401Phase 1/21 trial
selatinib ditosilate tabletsPhase 11 trial
Active Trials
NCT01931943Unknown
NCT07173556Not Yet RecruitingEst. Oct 2028
Debiopharm
DebiopharmSwitzerland - Lausanne
1 program
1
Debio 0123 and Sacituzumab govitecanPhase 1/2ADC
HB
HaiHe BiopharmaChina - Shanghai
1 program
1
CYH33Phase 11 trial
Active Trials
NCT04856371UnknownEst. Dec 2022
Bristol Myers Squibb
1 program
1
DasatinibPhase 1Small Molecule1 trial
Active Trials
NCT00452673Completed52Est. Oct 2012
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
1
NanoxelPhase 11 trial
Active Trials
NCT00915369Unknown24Est. Apr 2010
TerSera Therapeutics
TerSera TherapeuticsIL - Deerfield
1 program
1
ZOLADEXPhase 11 trial
Active Trials
NCT07310420Not Yet RecruitingEst. Mar 2027
E
EisaiChina - Liaoning
1 program
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A
Pfizer
PfizerNEW YORK, NY
1 program
Southeast Netherlands Advanced Metastatic Breast Cancer RegistryN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Stemline TherapeuticsEverolimus
NovartisTrastuzumab
Pierre FabreVinflunine+Gemcitabine
AstraZenecaFulvestrant
NovartisTrastuzumab
AstraZenecaCamizestrant
Daiichi SankyoTrastuzumab deruxtecan
AstraZenecaGoserelin acetate
NovartisTrastuzumab
Qilu PharmaceuticalQLC1401
Gilead SciencesDebio 0123 and Sacituzumab govitecan
Chia Tai TianQing Pharmaceutical GroupTQB3909 tablets
NovartisTrastuzumab
TerSera TherapeuticsZOLADEX
Stemline TherapeuticsMEN2312

Showing 15 of 23 trials with date data

Clinical Trials (23)

Total enrollment: 10,720 patients across 23 trials

NCT06382948Stemline TherapeuticsEverolimus

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Start: Dec 2024Est. completion: Apr 2028240 patients
Phase 3Recruiting
NCT05063786NovartisTrastuzumab

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

Start: Sep 2021Est. completion: Jun 202627 patients
Phase 3Active Not Recruiting
NCT02054338Pierre FabreVinflunine+Gemcitabine

A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer

Start: Jun 2006Est. completion: Feb 20151,004 patients
Phase 3Terminated
NCT00635713AstraZenecaFulvestrant

Second Line Breast Cancer Trial

Start: May 1997Est. completion: Sep 2004588 patients
Phase 3Completed
NCT05722886NovartisTrastuzumab

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol

Start: Mar 2023Est. completion: Oct 2029825 patients
Phase 2/3Recruiting
NCT07427394AstraZenecaCamizestrant

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Start: Apr 2026Est. completion: Dec 202724 patients
Phase 2Not Yet Recruiting
NCT04420598Daiichi SankyoTrastuzumab deruxtecan

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

Start: May 2020Est. completion: Apr 202341 patients
Phase 2Completed
NCT00322348AstraZenecaGoserelin acetate

Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

Start: Apr 2006Est. completion: Nov 200998 patients
Phase 2Completed
NCT07136428NovartisTrastuzumab

Asciminib in HER2+ Breast Cancer Brain Metastases

Start: Feb 2026Est. completion: Nov 203242 patients
Phase 1/2Not Yet Recruiting
NCT07173556Qilu PharmaceuticalQLC1401

A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer

Start: Sep 2025Est. completion: Oct 2028
Phase 1/2Not Yet Recruiting
NCT06612203Gilead SciencesDebio 0123 and Sacituzumab govitecan

Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer

Start: Jan 2025Est. completion: Oct 202776 patients
Phase 1/2Active Not Recruiting
NCT05775575Chia Tai TianQing Pharmaceutical GroupTQB3909 tablets

A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

Start: Mar 2023Est. completion: Dec 2023
Phase 1/2Unknown
NCT00216047NovartisTrastuzumab

PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

Start: Jan 2005Est. completion: Aug 20067 patients
Phase 1/2Terminated
NCT07310420TerSera TherapeuticsZOLADEX

A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Start: Feb 2026Est. completion: Mar 2027
Phase 1Not Yet Recruiting
NCT06638307Stemline TherapeuticsMEN2312

A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Start: Oct 2024Est. completion: Oct 2026240 patients
Phase 1Recruiting
NCT04856371HaiHe BiopharmaCYH33

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Start: Apr 2021Est. completion: Dec 2022
Phase 1Unknown
NCT03850873Chia Tai TianQing Pharmaceutical GroupTQB3616

A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

Start: Mar 2019Est. completion: Sep 2021
Phase 1Unknown
NCT01931943Qilu Pharmaceuticalselatinib ditosilate tablets

A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

Start: Apr 2013
Phase 1Unknown
NCT01602406NovartisTrastuzumab

Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer

Start: Sep 2012Est. completion: Aug 201764 patients
Phase 1Completed
NCT00915369Fresenius KabiNanoxel

A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer

Start: Mar 2009Est. completion: Apr 201024 patients
Phase 1Unknown
NCT00452673Bristol Myers SquibbDasatinib

Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

Start: Jun 2007Est. completion: Oct 201252 patients
Phase 1Completed
NCT06500494Pierre FabreVinorelbine Tartrate Oral

To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment

Start: Sep 2024Est. completion: Feb 2028368 patients
N/ARecruiting
NCT03577197Gilead SciencesSoutheast Netherlands Advanced Metastatic Breast Cancer Registry

Southeast Netherlands Advanced Metastatic Breast Cancer Registry

Start: Jan 2007Est. completion: Dec 20277,000 patients
N/ARecruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
5 actively recruiting trials targeting 10,720 patients
18 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)