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 (NCI Drug Dictionary). Faslodex (fulvestrant) 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 17 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
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
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

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02206984 Phase I Tamoxifen Anastrozole Fulvestrant Endocrine Response in Women With Invasive Lobular Breast Cancer Recruiting
NCT01528345 Phase II Dovitinib + Fulvestrant Fulvestrant Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer Terminated
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) Recruiting
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
NCT02340221 Phase III Fulvestrant Taselisib SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy Active, not recruiting
NCT02756364 Phase II Fulvestrant + Sapanisertib Fulvestrant MLN0128 in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy Completed
NCT02753686 Phase I Tamoxifen Exemestane Fulvestrant Letrozole Anastrozole Everolimus + Exemestane Treatment of Canadian Postmenopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy (Treat ER+ight) Recruiting
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 Active, not recruiting
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
NCT02540330 Phase II Fulvestrant PK Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy Recruiting
NCT02964507 Phase II Fulvestrant Fulvestrant + Molibresib Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Estrogen Receptor Positive (ER+) Breast Cancer Active, not recruiting
NCT02955394 Phase II Fulvestrant Enzalutamide + Fulvestrant Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Recruiting
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. Active, not recruiting
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Phase II Study of Everolimus Beyond Progression Active, not recruiting
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) Recruiting
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
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) Recruiting
NCT03147287 Phase II Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant Palbociclib After CDK and Endocrine Therapy (PACE) Recruiting
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
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 Recruiting
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 Active, not recruiting
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 Recruiting
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
NCT00921115 Phase II Anastrozole Fulvestrant Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer. Active, not recruiting
NCT04214288 Phase II AZD9833 Fulvestrant A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer (SERENA-2) Recruiting
NCT02692755 Phase II Fulvestrant Letrozole + Palbociclib Palbociclib / Letrozole in African American Women With HR+ HER2- Breast Cancer (PALINA) Active, not recruiting
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
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
NCT02947685 Phase III Fulvestrant Pertuzumab Letrozole Anastrozole Exemestane Trastuzumab Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) Recruiting
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
NCT01953588 Phase III Anastrozole Fulvestrant Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery Active, not recruiting
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
NCT03781063 Phase II Lasofoxifene Fulvestrant Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Recruiting
NCT03241810 Phase II Fulvestrant Fulvestrant + Seribantumab Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer (SHERBOC) Terminated
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
NCT02936206 Phase I Tamoxifen Fulvestrant Examination of Breast Cancer Cells of Pre-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant. Recruiting
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) Recruiting
NCT02913430 Phase II Tamoxifen Fulvestrant Phase II Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen Recruiting
NCT02422615 Phase III Fulvestrant Fulvestrant + Ribociclib Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3) Active, not recruiting
NCT02137837 Phase III Everolimus + Fulvestrant Anastrozole + Everolimus + Fulvestrant Fulvestrant S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer Terminated
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 Recruiting
NCT01560416 Phase II Fulvestrant Ganetespib Fulvestrant With or Without Ganetespib in HR+ Breast Cancer Completed
NCT01797120 Phase II Everolimus + Fulvestrant Fulvestrant Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI Completed
NCT01437566 Phase II GDC-0980 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
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 Recruiting


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