Therapy Detail

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Therapy Name Fulvestrant
Synonyms
Therapy Description

Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fulvestrant Faslodex ICI 182,780 Hormone - Anti-estrogens 25 Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant estrogen-receptor positive breast cancer no benefit Fulvestrant Phase II Actionable In a Phase II trial, Falsodex (fulvestrant) treatment resulted in similar progression free survival in ER positive breast cancer patients harboring PIK3CA mutations and those who were PIK3CA wild-type (PMID: 27174596). 27174596
EML4 - ALK breast cancer resistant Fulvestrant Preclinical - Cell culture Actionable In a preclinical study, breast cancer cells expressing EML4-ALK demonstrated resistance to treatment with Faslodex (fulvestrant) in culture (PMID: 32348852). 32348852

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03241810 Phase II Fulvestrant Fulvestrant + Seribantumab Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer (SHERBOC) Terminated USA | ESP | DEU | CAN | BEL | AUT 0
NCT02206984 Phase I Tamoxifen Anastrozole Fulvestrant Endocrine Response in Women With Invasive Lobular Breast Cancer Recruiting USA 0
NCT02437318 Phase III Alpelisib Fulvestrant 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. (SOLAR-1) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 21
NCT02219789 Phase I Fulvestrant Alisertib 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 USA 0
NCT02753686 Phase I Tamoxifen Exemestane Fulvestrant Letrozole Anastrozole Everolimus + Exemestane Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy (Treat ER+ight) Completed CAN 0
NCT01560416 Phase II Fulvestrant Ganetespib Fulvestrant With or Without Ganetespib in HR+ Breast Cancer Completed USA 0
NCT04214288 Phase II Camizestrant Fulvestrant A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer (SERENA-2) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 8
NCT02340221 Phase III Fulvestrant + Taselisib Fulvestrant 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 (SANDPIPER) Terminated USA | ITA | FRA | ESP | DEU | CAN | AUT | AUS 20
NCT03147287 Phase II Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant Palbociclib After CDK and Endocrine Therapy (PACE) Active, not recruiting USA 0
NCT02422615 Phase III Fulvestrant Fulvestrant + Ribociclib Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 20
NCT02540330 Phase II Fulvestrant A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant (007) Terminated USA 0
NCT02684032 Phase I Letrozole Fulvestrant Gedatolisib + Palbociclib 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 USA 0
NCT01797120 Phase II Everolimus + Fulvestrant Fulvestrant Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI Completed USA 0
NCT05038735 Phase III Alpelisib + Fulvestrant Fulvestrant Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5) Recruiting ITA | FRA | ESP | DEU | CAN | BEL 11
NCT01633060 Phase III Fulvestrant Buparlisib + Fulvestrant 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 USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT 13
NCT05472792 Phase II Toremifene Exemestane Tamoxifen Letrozole Anastrozole Fulvestrant Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) Recruiting USA 0
NCT03781063 Phase II Lasofoxifene Fulvestrant Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Active, not recruiting USA | CAN 1
NCT03926936 Phase II Fulvestrant FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study (FUCHSia) Recruiting BEL 0
NCT03778931 Phase III Letrozole Exemestane Elacestrant Fulvestrant Anastrozole Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD) Active, not recruiting USA | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS 8
NCT04576455 Phase II Fulvestrant Giredestrant A Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Active, not recruiting USA | GBR | DEU | AUS 13
NCT02137837 Phase III Everolimus + Fulvestrant Anastrozole + Everolimus + Fulvestrant Fulvestrant S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer Terminated USA 0
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Not yet recruiting USA 0
NCT02983604 Phase Ib/II Exemestane Fulvestrant + GS-5829 Exemestane + GS-5829 Fulvestrant GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer Terminated USA 0
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Phase II Study of Everolimus Beyond Progression Terminated USA 0
NCT01610284 Phase III Buparlisib + Fulvestrant Fulvestrant Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2)r Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
NCT02756364 Phase II Fulvestrant + Sapanisertib Fulvestrant MLN0128 in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy Completed USA | ESP 0
NCT02630693 Phase II Palbociclib Fulvestrant Tamoxifen Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer Completed CAN 0
NCT02366130 Phase II Tamoxifen Denosumab + Radium Ra 223 dichloride Fulvestrant Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer Completed USA 0
NCT03280563 Phase Ib/II Atezolizumab + Ipatasertib Atezolizumab + Bevacizumab + Exemestane Atezolizumab + Cobimetinib Atezolizumab + Bevacizumab + Fulvestrant Atezolizumab + Bevacizumab + Tamoxifen Atezolizumab + Fulvestrant + Ipatasertib Fulvestrant Atezolizumab + Fulvestrant A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS HR+BC) Active, not recruiting USA 2
NCT01437566 Phase II Apitolisib Fulvestrant Pictilisib Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 14
NCT03182634 Phase II Fulvestrant Ceralasertib + Olaparib Capivasertib Fulvestrant + Neratinib The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial (plasmaMATCH) Recruiting GBR 0
NCT04650581 Phase III Fulvestrant Fulvestrant + Ipatasertib 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 (FINER) Recruiting CAN | AUS 1
NCT05191004 Phase Ib/II NUV-422 Fulvestrant + NUV-422 Fulvestrant Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Withdrawn USA 0
NCT01528345 Phase II Dovitinib + Fulvestrant Fulvestrant Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer Terminated USA | ITA | FRA | ESP | BEL | AUT 9
NCT02632045 Phase II Fulvestrant + Ribociclib Fulvestrant Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer (MAINTAIN) Active, not recruiting USA 0
NCT03584009 Phase II Fulvestrant Fulvestrant + Venetoclax 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 USA | GBR | DEU | CAN | AUS 0
NCT02374099 Phase II Azacitidine Fulvestrant Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant Terminated USA | ITA | FRA | ESP | DEU | BEL 0
NCT00921115 Phase II Anastrozole Fulvestrant Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer. Completed USA 0
NCT02955394 Phase II Fulvestrant Enzalutamide + Fulvestrant Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Active, not recruiting USA 0
NCT02569801 Phase II GDC-0810 Fulvestrant A Study of GDC-0810 Versus Fulvestrant in Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy Terminated USA | GBR | ESP | DEU | AUS 1
NCT02107703 Phase III Abemaciclib + Fulvestrant Fulvestrant A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS 12
NCT02626507 Phase I Palbociclib Gedatolisib Goserelin Fulvestrant Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer Active, not recruiting USA 0
NCT02476786 Phase II Anastrozole Fulvestrant Goserelin Tamoxifen Exemestane Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score Recruiting USA 0
NCT02345772 Phase I Fulvestrant Docetaxel + Pertuzumab + Trastuzumab Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer Terminated USA 0
NCT02936206 Phase I Tamoxifen Fulvestrant Examination of Breast Cancer Cells of Pre-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant. Terminated USA 0
NCT01296555 Phase I Fulvestrant Taselisib Letrozole A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors And in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer Completed USA | FRA | ESP | CAN 0
NCT05501886 Phase III Alpelisib + Fulvestrant Fulvestrant + Gedatolisib + Palbociclib Fulvestrant + Gedatolisib Fulvestrant 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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
NCT05065411 Phase III Fulvestrant Exemestane Abemaciclib + Enobosarm Everolimus + Exemestane Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (VERU-024) Recruiting USA 0
NCT03555877 Phase II Anastrozole Fulvestrant Fulvestrant + Ribociclib Letrozole Exemestane + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Exemestane Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer (AMICA) Active, not recruiting DEU 0
NCT05169567 Phase III Fulvestrant Abemaciclib + Fulvestrant Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH) Recruiting USA | ITA | FRA | ESP | BEL 12
NCT01953588 Phase III Anastrozole Fulvestrant Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery Active, not recruiting USA 1
NCT04305496 Phase III Capivasertib + Fulvestrant Fulvestrant Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer (CAPItello-291) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 10
NCT02964507 Phase II Fulvestrant Fulvestrant + Molibresib Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer Completed USA | GBR | FRA | ESP | CAN | AUS 1
NCT02260661 Phase I Fulvestrant AZD8835 Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours Completed USA | GBR 0
NCT03809988 Phase II Fulvestrant Fulvestrant + Palbociclib Letrozole Letrozole + Palbociclib PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) Completed ITA | GBR | FRA | ESP | DEU 1
NCT02947685 Phase III Fulvestrant Pertuzumab Letrozole Anastrozole Exemestane Palbociclib Trastuzumab Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) Active, not recruiting USA | ITA | FRA | ESP | DEU | AUS 2
NCT05654623 Phase III Fulvestrant ARV-471 A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. (VERITAC-2) Recruiting USA | ITA | FRA | ESP | CAN | BEL | AUS 10
NCT05564377 Phase II Selumetinib Olaparib + Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Sotorasib Ipatasertib + Paclitaxel Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Registration Trial Recruiting USA 1
NCT04975308 Phase III Exemestane Abemaciclib + LY3484356 LY3484356 Fulvestrant A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) Recruiting USA | ITA | FRA | ESP | DEU | BEL | AUT | AUS 14
NCT05554354 Phase II Binimetinib + Fulvestrant Fulvestrant Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer, A ComboMATCH Treatment Trial Recruiting USA 1
NCT03355157 FDA approved Exemestane + Palbociclib Tamoxifen Paclitaxel Exemestane Capecitabine Palbociclib + Tamoxifen Epirubicin Vinorelbine Fulvestrant + Palbociclib Fulvestrant Letrozole Letrozole + Palbociclib A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). (PADMA) Recruiting DEU 0


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