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DRUG:
Orserdu (elacestrant)
i
Other names:
RAD1901
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News alerts, weekly reports and conference planners
Associations
(9)
News
Trials
Company:
DRI Healthcare, Menarini, Radius, SciClone
Drug class:
Selective estrogen receptor degrader
Related drugs:
‹
fulvestrant (57)
SAR439859 (9)
imlunestrant (7)
AZD9833 (7)
OP-1250 (7)
SCR-6852 (4)
GDC-9545 (4)
ZN-c5 (3)
AZD9496 (2)
GDC-0927 (2)
G1T48 (2)
LX-039 (1)
SCR6106 (1)
D-0502 (1)
AND019 (0)
DZD3969 (0)
LSZ102 (0)
SHR9549 (0)
GDC-0810 (0)
EGL-5385-C-1701 (0)
fulvestrant (57)
SAR439859 (9)
imlunestrant (7)
AZD9833 (7)
OP-1250 (7)
SCR-6852 (4)
GDC-9545 (4)
ZN-c5 (3)
AZD9496 (2)
GDC-0927 (2)
G1T48 (2)
LX-039 (1)
SCR6106 (1)
D-0502 (1)
AND019 (0)
DZD3969 (0)
LSZ102 (0)
SHR9549 (0)
GDC-0810 (0)
EGL-5385-C-1701 (0)
›
Associations
(9)
News
Trials
Phase
Status
Apply
Phase
Status
Apply
Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (NCT05573126)
Phase 1/2
Ellipses Pharma
Ellipses Pharma
Recruiting
Phase 1/2
Ellipses Pharma
Recruiting
Last update posted :
02/21/2025
Initiation :
01/11/2023
Primary completion :
11/01/2025
Completion :
11/01/2026
HER-2
|
HER-2 negative
|
everolimus • Orserdu (elacestrant) • vosilasarm (EP0062)
A Study of Samuraciclib and Elacestrant in Participants with Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (SUMIT-ELA) (NCT05963997)
Phase 1/2
Carrick Therapeutics Limited
Carrick Therapeutics Limited
Active, not recruiting
Phase 1/2
Carrick Therapeutics Limited
Active, not recruiting
Last update posted :
02/21/2025
Initiation :
10/09/2023
Primary completion :
12/23/2025
Completion :
12/23/2025
HER-2 • ER • TP53 • CDK4
|
TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
|
Orserdu (elacestrant) • samuraciclib (CT7001)
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE) (NCT05563220)
Phase 1/2
Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc.
Recruiting
Phase 1/2
Stemline Therapeutics, Inc.
Recruiting
Last update posted :
02/18/2025
Initiation :
01/24/2023
Primary completion :
12/27/2026
Completion :
12/28/2028
HER-2 • ER • PIK3CA • CDK4
|
PIK3CA mutation
|
Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer (ELECTRA) (NCT05386108)
Phase 1/2
Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc.
Recruiting
Phase 1/2
Stemline Therapeutics, Inc.
Recruiting
Last update posted :
02/11/2025
Initiation :
08/31/2022
Primary completion :
12/01/2025
Completion :
12/01/2025
HER-2 • ER • PGR
|
ER positive • HER-2 negative • HER-2 negative + ER positive
|
Verzenio (abemaciclib) • Orserdu (elacestrant)
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (ELCIN) (NCT05596409)
Phase 2
Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc.
Recruiting
Phase 2
Stemline Therapeutics, Inc.
Recruiting
Last update posted :
02/07/2025
Initiation :
05/19/2023
Primary completion :
02/01/2025
Completion :
08/01/2025
HER-2 • ER
|
Orserdu (elacestrant)
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (ADELA) (NCT06382948)
Phase 3
MedSIR
MedSIR
Not yet recruiting
Phase 3
MedSIR
Not yet recruiting
Last update posted :
04/26/2024
Initiation :
06/01/2024
Primary completion :
09/01/2027
Completion :
04/01/2028
HER-2 • ER • CDK4
|
HER-2 mutation • ER mutation • ESR1 mutation • CDK4 mutation
|
everolimus • Orserdu (elacestrant)
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD) (NCT03778931)
Phase 3
Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc.
Active, not recruiting
Phase 3
Stemline Therapeutics, Inc.
Active, not recruiting
Last update posted :
03/29/2024
Initiation :
05/10/2019
Primary completion :
08/24/2021
Completion :
08/01/2024
HER-2 • ER
|
fulvestrant • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (NCT06075953)
Phase 2
QuantumLeap Healthcare Collaborative
QuantumLeap Healthcare Collaborative
Recruiting
Phase 2
QuantumLeap Healthcare Collaborative
Recruiting
Last update posted :
03/27/2024
Initiation :
02/14/2024
Primary completion :
11/01/2028
Completion :
11/01/2033
HER-2
|
HR positive
|
tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (SOLTI-2104) (NCT05982093)
Phase 2
SOLTI Breast Cancer Research Group
SOLTI Breast Cancer Research Group
Recruiting
Phase 2
SOLTI Breast Cancer Research Group
Recruiting
Last update posted :
02/13/2024
Initiation :
10/03/2023
Primary completion :
10/01/2024
Completion :
01/01/2025
HER-2 • ER • PGR
|
ER positive • HER-2 negative • HER-2 expression
|
Orserdu (elacestrant) • triptorelin
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) (NCT05512364)
Phase 3
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and ...
Recruiting
Phase 3
European Organisation for Research and Treatmen...
Recruiting
Last update posted :
01/24/2024
Initiation :
12/15/2023
Primary completion :
07/01/2028
Completion :
05/01/2030
HER-2 • ER • PGR
|
ER positive • HER-2 negative • ER positive + HER-2 negative
|
tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer (ELEMENT) (NCT06201234)
Phase 2
German Breast Group
German Breast Group
Not yet recruiting
Phase 2
German Breast Group
Not yet recruiting
Last update posted :
01/11/2024
Initiation :
03/31/2024
Primary completion :
03/31/2028
Completion :
03/31/2028
HER-2 • BRCA1
|
HER-2 negative • PALB2 mutation • PTEN mutation + HR positive
|
Zejula (niraparib) • Orserdu (elacestrant)
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer (NCT06062498)
Phase 2
Northwestern University
Northwestern University
Not yet recruiting
Phase 2
Northwestern University
Not yet recruiting
Last update posted :
10/02/2023
Initiation :
09/30/2023
Primary completion :
07/01/2024
Completion :
07/01/2025
HER-2 • ER
|
ER positive • HER-2 negative • ER mutation • ESR1 mutation
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Orserdu (elacestrant)
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (NCT05826964)
Phase 2
University of Miami
University of Miami
Recruiting
Phase 2
University of Miami
Recruiting
Last update posted :
08/21/2023
Initiation :
06/12/2023
Primary completion :
07/31/2026
Completion :
07/31/2029
HER-2 • ER
|
HER-2 negative
|
Ibrance (palbociclib) • everolimus • tamoxifen • capecitabine • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • anastrozole • exemestane • Orserdu (elacestrant) • Navelbine oral (vinorelbine tartrate oral)
Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer (Lilly-I3Y-US-I026) (NCT04791384)
Phase 1/2
Criterium, Inc.
Criterium, Inc.
Recruiting
Phase 1/2
Criterium, Inc.
Recruiting
Last update posted :
07/27/2023
Initiation :
04/21/2022
Primary completion :
12/01/2024
Completion :
01/01/2025
HER-2 • ER • PGR
|
ER positive + PGR positive
|
Verzenio (abemaciclib) • Orserdu (elacestrant)
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer (ELONA) (NCT05618613)
Phase 1b
Context Therapeutics Inc.
Context Therapeutics Inc.
Active, not recruiting
Phase 1b
Context Therapeutics Inc.
Active, not recruiting
Last update posted :
03/28/2023
Initiation :
12/02/2022
Primary completion :
12/31/2024
Completion :
04/30/2026
HER-2
|
Orserdu (elacestrant) • Apristor (onapristone XR)
Elacestrant in Preoperative Setting, a Window of Opportunity Study (ELIPSE) (NCT04797728)
Phase 1
SOLTI Breast Cancer Research Group
SOLTI Breast Cancer Research Group
Completed
Phase 1
SOLTI Breast Cancer Research Group
Completed
Last update posted :
10/26/2022
Initiation :
02/09/2021
Primary completion :
02/08/2022
Completion :
02/25/2022
HER-2 • ER • PIK3CA • PTTG1 • RRM2 • CDC20 • CEP55 • UBE2C
|
HER-2 negative • PIK3CA mutation
|
Orserdu (elacestrant)
Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer (NCT02650817)
Phase 1
Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc.
Completed
Phase 1
Stemline Therapeutics, Inc.
Completed
Last update posted :
08/18/2022
Initiation :
04/01/2016
Primary completion :
08/30/2018
Completion :
10/18/2019
HER-2 • ER
|
ER positive • HER-2 negative • EGFR positive • ER expression
|
Orserdu (elacestrant)
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