Faslodex

(Fulvestrant)

ApprovedSmall molecule

Fulvestrant is used to treat hormone receptor-positive breast cancer in postmenopausal women. It works by blocking estrogen receptors on cancer cells, preventing estrogen from fueling their growth.[2] Faslodex is currently approved and in use across 39 indications[4].[1]

Faslodex is one of 590 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

390

Total Trials

Active Trials

589

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusApproved

Prostate AdenocarcinomaApproved

Uterine Corpus CancerApproved

LymphomaApproved

Pancreatic Neuroendocrine TumorRecruiting

Overall SurvivalActive, not recruiting

Breast NeoplasmActive, not recruiting

Breast CarcinomaTerminated

Precocious PubertyApproved

Genital Neoplasm, FemaleApproved

Systemic Lupus ErythematosusApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Uterine Corpus CancerApproved

Approved

LymphomaApproved

Approved

Pancreatic Neuroendocrine TumorPhase 1

Recruiting

Overall SurvivalPreclinical

Active, not recruiting

Breast NeoplasmApproved

Active, not recruiting

Breast CarcinomaApproved

Terminated

Precocious PubertyApproved

Approved

Genital Neoplasm, FemaleApproved

Approved

Showing 10 of 39 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Faslodex

FFresenius Kabi USA, LLC

Lexiscan

1 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Tricor

JJagotec

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT02057133

Phase 1Not yet recruiting

Postmenopausal Women

NCT07366632

Phase 3Active, not recruiting

Breast Cancer

NCT04650581

Phase 3Active, not recruiting

Breast Cancer

NCT05501886

Q1 2027

Phase 2Recruiting

Ovarian Cancer

NCT05113368

Phase 1/2Recruiting

Patients With Solid Tumors

NCT06208410

Clinical

Trials by Indication[1]

Breast Cancer137 trials

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04985266·1,100 enrolled

A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT06941142·382 enrolled

I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

Not yet recruiting·IInstitut Paoli-Calmettes·Phase 1/2·NCT05986071·57 enrolled

Show 134 more trials

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1/2·NCT07389733·180 enrolled

A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT04355520·42 enrolled

Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer

Recruiting·GGBG Forschungs GmbH·Phase 2·NCT06607757·120 enrolled

A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT04796623·120 enrolled

BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Active, not recruiting· BeiGene logo

BeiGene·Phase 1·NCT06253195·33 enrolled

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02738866·60 enrolled

Second Line Breast Cancer Trial

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00635713·588 enrolled

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT04060862·20 enrolled

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

Completed·IInstitut Bergonié·Phase 2·NCT00871858·120 enrolled

Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00259090·120 enrolled

ICI 182780 in Treating Women With Metastatic Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00012025·80 enrolled

Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

Completed·UUNICANCER·Phase 2·NCT00629616·116 enrolled

Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

Terminated·—·Phase 2·NCT03289039·21 enrolled

Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer

Completed·MMassachusetts General Hospital·Phase 2·NCT01441947·68 enrolled

S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

Terminated·SSWOG Cancer Research Network·Phase 3·NCT02137837·37 enrolled

Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT01670877·56 enrolled

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02333370·88 enrolled

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00075764·695 enrolled

Clinical Study of Chidamide Combined With Fulvestrant in the Treatment of Hormone Receptor-positive Advanced Breast Cancer

Unknown status·LLiaoning Cancer Hospital & Institute·N/A·NCT05047848·82 enrolled

Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer

Completed·CCalithera Biosciences, Inc·Phase 2·NCT02049957·118 enrolled

Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00451555·156 enrolled

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT05601440·484 enrolled

HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

Terminated·TTheodoros Foukakis·Phase 2·NCT03322215·42 enrolled

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting·—·Phase 2·NCT05933395·135 enrolled

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05216432·930 enrolled

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Completed·—·Phase 1/2·NCT02657343·25 enrolled

Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

Recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT05319873·18 enrolled

G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Unknown status·GG1 Therapeutics, Inc.·Phase 1/2·NCT02983071·102 enrolled

A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

Recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06202261·154 enrolled

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Completed·GGBG Forschungs GmbH·Phase 2·NCT03555877·56 enrolled

Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)

Terminated·UUniversity of Wisconsin, Madison·Phase 2·NCT04738292·11 enrolled

Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure

Completed·MMara Chambers·Phase 2·NCT00570921·33 enrolled

Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

Completed·MMayo Clinic·Phase 1·NCT02219789·10 enrolled

Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer

Terminated· GSK logo

GSK·Phase 1·NCT02964507·124 enrolled

Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer

Unknown status·FFudan University·Phase 1/2·NCT03772353·59 enrolled

A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer

Completed·FFudan University·Phase 2·NCT02137083·22 enrolled

A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07235618·50 enrolled

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Unknown status·BBetta Pharmaceuticals Co., Ltd.·Phase 3·NCT05433480·274 enrolled

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT02760030·14 enrolled

Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy

Completed·CCalithera Biosciences, Inc·Phase 2·NCT02756364·141 enrolled

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03099174·133 enrolled

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

Completed·MMelissa K Accordino·Phase 2·NCT02632045·169 enrolled

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT03554044·20 enrolled

Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00390455·295 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer

Withdrawn·SSyndax Pharmaceuticals·Phase 2·NCT02115594

WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor

Completed·GGeorgetown University·Phase 1·NCT03854903·19 enrolled

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed·CCelcuity Inc·Phase 1·NCT02684032·141 enrolled

SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer

Completed·EEvgen Pharma·Phase 2·NCT02970682·60 enrolled

AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00454805·75 enrolled

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Not yet recruiting·FFudan University·Phase 2·NCT06561022·260 enrolled

Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.

Completed·UUniversity of Kansas Medical Center·Phase 2·NCT00921115·42 enrolled

ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00752986·39 enrolled

Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00057941·148 enrolled

Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00372996·219 enrolled

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02057133·198 enrolled

Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT01597193·101 enrolled

MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

Completed· Menarini logo

Menarini·Phase 1·NCT03767335·62 enrolled

Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05806671·30 enrolled

Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Completed·—·Phase 2·NCT00146601·35 enrolled

Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00201864·40 enrolled

A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer

Completed·QQueen Mary University of London·Phase 2·NCT02216786·333 enrolled

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

Completed·CCarrick Therapeutics Limited·Phase 2·NCT05963984·60 enrolled

Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00423917·36 enrolled

Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00357110·13 enrolled

Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant

Terminated· Novartis logo

Novartis·Phase 2·NCT04862143·2 enrolled

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

Completed·IiOMEDICO AG·Phase 2·NCT02894398·388 enrolled

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT05554354·1 enrolled

A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00274469·205 enrolled

A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT03927456·357 enrolled

Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00405938·79 enrolled

Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Completed· AstraZeneca logo

AstraZeneca··NCT00660803·200 enrolled

The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer

Unknown status·—·Phase 2·NCT02072512·180 enrolled

The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial

Unknown status·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT03182634·1,150 enrolled

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer

Completed·LLund University Hospital·Phase 2·NCT02958852·126 enrolled

Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

Completed·—·Phase 2·NCT01560416·50 enrolled

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

Active, not recruiting·BBorstkanker Onderzoek Groep·Phase 2·NCT05392608·130 enrolled

CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer

Active, not recruiting·TTreadwell Therapeutics, Inc·Phase 1/2·NCT05251714·44 enrolled

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Unknown status·FFudan University··NCT02909361·500 enrolled

Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer

Active, not recruiting·BBorstkanker Onderzoek Groep·Phase 3·NCT03425838·1,050 enrolled

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Active, not recruiting·CCriterium, Inc.·Phase 1/2·NCT05230810·40 enrolled

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05654623·624 enrolled

Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer

Terminated·EElevation Oncology·Phase 2·NCT03241810·22 enrolled

Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy

Terminated·UUniversity of Arkansas·Phase 2·NCT00570258·27 enrolled

A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03344536·10 enrolled

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Terminated· Novartis logo

Novartis·Phase 3·NCT01633060·432 enrolled

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Terminated· Roche logo

Roche·Phase 3·NCT02340221·631 enrolled

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT01202591·127 enrolled

Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

Active, not recruiting·—·Phase 2·NCT02778685·47 enrolled

Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT00903006·11 enrolled

Fulvestrant + Neratinib In Breast Cancer

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT04901299

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Not yet recruiting·TThe Affiliated Hospital of Qingdao University··NCT06341283·200 enrolled

Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01142401·118 enrolled

Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor

Recruiting·NNational University Hospital, Singapore·Phase 2·NCT05181033·120 enrolled

Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00774878·18 enrolled

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02088684·70 enrolled

A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy

Recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT07330544·118 enrolled

MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women With Metastatic Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01344031·31 enrolled

Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00093002·179 enrolled

Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Active, not recruiting·CCanadian Cancer Trials Group·Phase 3·NCT04650581·250 enrolled

Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

Completed·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT04258163·760 enrolled

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

Completed·MMedSIR·Phase 2·NCT02491983·486 enrolled

ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00010153

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Terminated· Roche logo

Roche·Phase 2·NCT03584009·103 enrolled

A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT03803761

Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

Completed·AAccelerated Community Oncology Research Network·Phase 2·NCT00534417·41 enrolled

Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00082810·33 enrolled

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Active, not recruiting·MMarina N Sharifi·Phase 2·NCT04762979·44 enrolled

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer

Recruiting·BBiotheryx, Inc.·Phase 1·NCT06515470·82 enrolled

Overcoming Endocrine Resistance in Metastatic Breast Cancer

Unknown status·CConsorzio Oncotech·Phase 3·NCT02394496·396 enrolled

Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Recruiting·WWenjin Yin·Phase 2·NCT07180160·123 enrolled

A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)

Unknown status·RRegina Elena Cancer Institute·Phase 2·NCT00927511·104 enrolled

Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02599714·54 enrolled

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Completed· Novartis logo

Novartis·Phase 3·NCT02437318·572 enrolled

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00065325·694 enrolled

Fulvestrant With or Without AZD6244 in Treating Patients With Advanced Breast Cancer That Progressed After Aromatase Inhibitor Therapy

Completed·SSwiss Cancer Institute·Phase 2·NCT01160718·46 enrolled

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Active, not recruiting·—·Phase 2·NCT03393845·47 enrolled

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

Recruiting·HHerui Yao·Phase 3·NCT04263298·210 enrolled

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Completed· Novartis logo

Novartis·Phase 2·NCT03056755·383 enrolled

Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer

Terminated·HHenan Cancer Hospital·Phase 1/2·NCT05176080·46 enrolled

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT02447328·83 enrolled

A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

Terminated· Roche logo

Roche·Phase 2·NCT02569801·71 enrolled

Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01300351·249 enrolled

Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-

Unknown status·—··NCT05140655·40 enrolled

The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer

Unknown status·FFudan University·Phase 2·NCT03202862·50 enrolled

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03377101

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02675231·237 enrolled

Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

Unknown status·GGruppo Italiano Mammella (GIM)·Phase 3·NCT00688194·396 enrolled

Faslodex Advanced Breast Cancer Local Chinese Study

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00327769·234 enrolled

AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01597388·99 enrolled

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer

Completed· Gilead logo

Gilead·Phase 1·NCT02392611·33 enrolled

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 2·NCT04059484·367 enrolled

Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Completed·SSermonix Pharmaceuticals Inc.·Phase 2·NCT03781063·100 enrolled

Non-Small Cell Lung Cancer3 trials

Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

Terminated·UUniversity of Pittsburgh·Phase 2·NCT00932152·3 enrolled

Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Completed·TTranslational Oncology Research International·Phase 2·NCT00100854·108 enrolled

QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors

Withdrawn·IImmunityBio, Inc.·Phase 1/2·NCT03169738

Efficacy and Safety3 trials

Efficacy and Safety of 500mg of Fulvestrant

Active, not recruiting·—·Phase 2·NCT00585507·40 enrolled

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Recruiting·SSeoul National University Hospital·Phase 2·NCT05536128·64 enrolled

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02374099·97 enrolled

Ovarian Cancer3 trials

Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

Terminated·—·Phase 1·NCT03294694·33 enrolled

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Recruiting·—·Phase 2·NCT05113368·31 enrolled

Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)

Recruiting·UUniversity of Oklahoma·Phase 2·NCT06494150·37 enrolled

Advanced Solid Tumors3 trials

A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors

Completed·SSyros Pharmaceuticals·Phase 1·NCT04247126·105 enrolled

(VELA) Study of BLU-222 in Advanced Solid Tumors

Terminated·BBlueprint Medicines·Phase 1·NCT05252416·50 enrolled

SNV4818 in Participants With Advanced Solid Tumors

Recruiting·PPikavation Therapeutics, Inc.·Phase 1/2·NCT06736704·320 enrolled

39 more indications

Prostate Cancer3 trials

Fulvestrant in Hormone Refractory Prostate Cancer

Completed·SStanford University·Phase 2·NCT00476645·10 enrolled

Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT00217464·17 enrolled

Fulvestrant in Treating Patients With Advanced Prostate Cancer

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00244998·20 enrolled

Postmenopausal Women2 trials

A Study of Single Dose of BL0175 in Postmenopausal Women

Not yet recruiting·SShanghai Best-Link Bioscience, LLC·Phase 1·NCT07366632·27 enrolled

Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women

Completed·SSpanish Breast Cancer Research Group·Phase 3·NCT00545077·380 enrolled

Patients With Solid Tumors2 trials

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors

Recruiting·RRisen (Suzhou) Pharma Tech Co., Ltd.·Phase 1/2·NCT06208410·306 enrolled

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Completed· Novartis logo

Novartis·Phase 2/3·NCT02116803·12 enrolled

Treatment2 trials

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

Completed·IIsabel Blancas··NCT01509625·272 enrolled

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Patients With Advanced Solid Tumors2 trials

A Study of SY-1365 in Adult Patients With Advanced Solid Tumors

Terminated·SSyros Pharmaceuticals·Phase 1·NCT03134638·107 enrolled

AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03310541·12 enrolled

Advanced Cancer2 trials

A Study of LY3023414 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01655225·156 enrolled

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Recruiting·IIncyclix Bio·Phase 1/2·NCT05735080·150 enrolled

Steroid2 trials

Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors

Completed·IInstitute of Cancer Research, United Kingdom·Phase 3·NCT00253422·698 enrolled

Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00944918·25 enrolled

Endocrine Therapy2 trials

Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

Completed·IIstituti Clinici Scientifici Maugeri SpA··NCT04524728·191 enrolled

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Completed·SSpanish Breast Cancer Research Group·Phase 3·NCT02028507·693 enrolled

Overall Survival1 trial

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

Completed·MMedSIR··NCT06525675·419 enrolled

Immunotherapy1 trial

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

Terminated·WWestern Regional Medical Center·Phase 1/2·NCT02345772·4 enrolled

Single Ascending Dose1 trial

Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study

Completed·KKashiv BioSciences, LLC·Phase 1·NCT06074757·48 enrolled

Tumor1 trial

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Completed·UUNICANCER·Phase 3·NCT03079011·1,017 enrolled

McCune-Albright syndrome1 trial

Faslodex in McCune-Albright Syndrome

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00278915·30 enrolled

Female1 trial

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers

Recruiting·KKashiv BioSciences, LLC·Phase 1·NCT06995482·40 enrolled

Pancreatic Cancer1 trial

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Bone Metastasis1 trial

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

Completed·EEmory University·Phase 2·NCT03691493·36 enrolled

Solid Tumor Cancer1 trial

A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT05054374·6 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Withdrawn·IImmunityBio, Inc.·Phase 1/2·NCT03169764

Abemaciclib1 trial

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

Completed·MMedSIR·Phase 2·NCT04603183·162 enrolled

Ptosis1 trial

"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

Completed·FFondazione Michelangelo·Phase 2·NCT02530424·102 enrolled

Growth1 trial

Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT06408168·6 enrolled

Recurrent Ovarian Epithelial Cancer1 trial

Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00617188·26 enrolled

Gynecologic Cancer1 trial

Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

Withdrawn·PPamela Munster·Phase 1·NCT04498520

Phase II1 trial

Phase II Study of Everolimus Beyond Progression

Terminated·EEmory University·Phase 2·NCT02269670·3 enrolled

Single Dose1 trial

Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02640755·4 enrolled

Combination Therapy1 trial

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00256698·514 enrolled

Metastatic Solid Tumor1 trial

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT07480681·138 enrolled

Pulmonary Arterial Hypertension1 trial

Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

Completed·UUniversity of Pennsylvania·Phase 2·NCT02911844·5 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

MPA1 trial

Impact of Endogenous E2 on SSI and GH Rebound

Completed·MMayo Clinic·Phase 1·NCT02026973·62 enrolled

Effectiveness1 trial

Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

Unknown status·CChinese Academy of Medical Sciences··NCT05000736·600 enrolled

Clinical Trial1 trial

A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00313170·144 enrolled

Surgical1 trial

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

Terminated·AAtossa Therapeutics, Inc.·Phase 2·NCT02540330·3 enrolled

Phase 21 trial

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT05082025·7 enrolled

Maintenance Therapy1 trial

Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients

Unknown status·CConsorzio Oncotech·Phase 3·NCT02383030·156 enrolled

HER21 trial

Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

Withdrawn·NNuvation Bio Inc.·Phase 1/2·NCT05191004

Solid Tumors1 trial

Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT02761694·78 enrolled

Advanced Solid Malignancies1 trial

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Completed· Novartis logo

Novartis·Phase 1·NCT01219699·221 enrolled

Unspecified4 trials

Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

Terminated·SSpanish Breast Cancer Research Group·Phase 3·NCT00543127·870 enrolled

Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC

Withdrawn·FFudan University·Phase 2·NCT02140437

VS-6766+Abema+Fulv in Met HR+/HER- BC

Recruiting·—·Phase 1/2·NCT05608252·63 enrolled

Show 1 more trial

Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00328120·20 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 25, 2002

FASLODEX

NDA NDA021344

Dec 24, 2003

FASLODEX

NDA NDA021344

Aug 2, 2005

FASLODEX

NDA NDA021344

Sep 9, 2010

FASLODEX

NDA NDA021344

Sep 9, 2010

FASLODEX

NDA NDA021344

May 17, 2011

FASLODEX

NDA NDA021344

Sep 26, 2011

FASLODEX

NDA NDA021344

Sep 26, 2011

FASLODEX

NDA NDA021344

Jul 13, 2012

FASLODEX

NDA NDA021344

Nov 9, 2012

FASLODEX

NDA NDA021344

Nov 9, 2012

FASLODEX

NDA NDA021344

Oct 8, 2013

FASLODEX

NDA NDA021344

Oct 8, 2013

FASLODEX

NDA NDA021344

Jun 30, 2014

FASLODEX

NDA NDA021344

Aug 25, 2014

FASLODEX

NDA NDA021344

Mar 1, 2016

FASLODEX

NDA NDA021344

Mar 2, 2016

FASLODEX

NDA NDA021344

May 19, 2016

FASLODEX

NDA NDA021344

Jul 12, 2016

FASLODEX

NDA NDA021344

Oct 26, 2016

FASLODEX

NDA NDA021344

Oct 31, 2016

FASLODEX

NDA NDA021344

Jan 24, 2017

FASLODEX

NDA NDA021344

Aug 25, 2017

FASLODEX

NDA NDA021344

Nov 14, 2017

FASLODEX

NDA NDA021344

Jul 5, 2018

FASLODEX

NDA NDA021344

Mar 11, 2019

FASLODEX

NDA NDA021344

May 20, 2019

FASLODEX

NDA NDA021344

May 20, 2019

FULVESTRANT

NDA NDA210326

Aug 19, 2019

FULVESTRANT

NDA NDA210063

Nov 21, 2019

FASLODEX

NDA NDA021344

May 13, 2020

FASLODEX

NDA NDA021344

Jul 28, 2020

FASLODEX

NDA NDA021344

Jan 19, 2021

FASLODEX

NDA NDA021344

Sources

References

[1]
ClinicalTrials.gov — 390 trial records for Fulvestrant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Faslodex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fulvestrant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fulvestrant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021344). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Faslodex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Fresenius Kabi USA, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Antagonist; Estrogen Receptor Degrader[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: FFresenius Kabi USA, LLC

Patent Landscape[6]

Patent Cliff

Feb 14, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9833459Feb 14, 2034

10188663Feb 14, 2034

9271990May 17, 2034

Faslodex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer137 trials

Non-Small Cell Lung Cancer3 trials

Efficacy and Safety3 trials

Ovarian Cancer3 trials

Advanced Solid Tumors3 trials

Prostate Cancer3 trials

Postmenopausal Women2 trials

Patients With Solid Tumors2 trials

Treatment2 trials

Patients With Advanced Solid Tumors2 trials

Advanced Cancer2 trials

Steroid2 trials

Endocrine Therapy2 trials

Overall Survival1 trial

Immunotherapy1 trial

Single Ascending Dose1 trial

Tumor1 trial

McCune-Albright syndrome1 trial

Female1 trial

Pancreatic Cancer1 trial

Bone Metastasis1 trial

Solid Tumor Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Abemaciclib1 trial

Ptosis1 trial

Growth1 trial

Recurrent Ovarian Epithelial Cancer1 trial

Gynecologic Cancer1 trial

Phase II1 trial

Single Dose1 trial

Combination Therapy1 trial

Metastatic Solid Tumor1 trial

Pulmonary Arterial Hypertension1 trial

Observational Study1 trial

MPA1 trial

Effectiveness1 trial

Clinical Trial1 trial

Surgical1 trial

Phase 21 trial

Maintenance Therapy1 trial

HER21 trial

Solid Tumors1 trial

Advanced Solid Malignancies1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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