Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD)

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ClinicalTrials.gov Identifier: NCT03778931

Recruitment Status : Active, not recruiting

First Posted : December 19, 2018

Results First Posted : December 5, 2023

Last Update Posted : March 29, 2024

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Sponsor:

Information provided by (Responsible Party):

Stemline Therapeutics, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Elacestrant Drug: Standard of Care
Enrollment	478

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
Period Title: Overall Study
Started	239	239
Intent-to-Treat Population	239	239
Safety Population	237	230
Completed	95 ^[1]	114 ^[1]
Not Completed	144	125
[1] Overall study includes survival follow-up; subjects designated as "Not Completed" were still in survival follow-up.

Baseline Characteristics

Arm/Group Title		Elacestrant	Standard of Care (SoC)	Total
Arm/Group Description		Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...	Total of all reporting groups
Arm/Group Description		Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule	Total of all reporting groups
Overall Number of Baseline Participants		239	239	478
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	239 participants	239 participants	478 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	135 56.5%	128 53.6%	263 55.0%
	>=65 years	104 43.5%	111 46.4%	215 45.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	239 participants	239 participants	478 participants
	Female	233 97.5%	238 99.6%	471 98.5%
	Male	6 2.5%	1 0.4%	7 1.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	239 participants	239 participants	478 participants
	Hispanic or Latino	19 7.9%	18 7.5%	37 7.7%
	Not Hispanic or Latino	194 81.2%	191 79.9%	385 80.5%
	Unknown or Not Reported	26 10.9%	30 12.6%	56 11.7%
Height ^[1] Mean (Standard Deviation) Unit of measure: Cm
	Number Analyzed	236 participants	237 participants	473 participants
		162.27 (7.860)	160.97 (7.149)	161.62 (7.532)
		[1] Measure Analysis Population Description: subjects were missing from these measures
Weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	239 participants	239 participants	478 participants
		72.70 (16.093)	72.39 (16.390)	72.55 (16.226)
Body Mass Index ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	236 participants	237 participants	473 participants
		27.58 (5.494)	27.92 (5.853)	27.75 (5.673)
		[1] Measure Analysis Population Description: 5 subjects missing
Eastern Cooperative Oncology Group Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants
0: Fully active, able to carry on all pre-disease performance without restriction	Number Analyzed	239 participants	239 participants	478 participants
		143 59.8%	135 56.5%	278 58.2%
1: Restricted in physically strenuous activity but ambulatory & can carry out light, sedentary work	Number Analyzed	239 participants	239 participants	478 participants
		96 40.2%	103 43.1%	199 41.6%
2: Ambulatory and capable of all selfcare but unable to carry out any work activities	Number Analyzed	239 participants	239 participants	478 participants
		0 0.0%	1 0.4%	1 0.2%
		[1] Measure Description: Participated were graded on a scale from 0 to 5, where 5 was worst: 0: Normal activity. Fully active, able to carry on all pre-disease performance w/o restriction Symptoms, but ambulatory. Restricted in strenuous activity, ambulatory and able to carry out light work In bed <50% of time. Ambulatory, capable of all self-care, unable to carry out any work activities In bed >50% of time. Capable of limited self-care 100% bedridden. Completely disabled. Cannot carry out any self-care. Confined to bed or chair Dead

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival in ESR1-mut Subjects
Description	Progression-free Survival based on blinded IRC assessment in ESR1-mut ...
Description	Progression-free Survival based on blinded IRC assessment in ESR1-mut subjects defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description:	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description:	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
Overall Number of Participants Analyzed	115	113
Median (95% Confidence Interval) Unit of Measure: months
	3.78 (2.17 to 7.26)	1.87 (1.87 to 2.14)

2.Primary Outcome


Title	Progression-free Survival in All Subjects
Description	Progression-free Survival based on blinded Imaging Review Committee (I...
Description	Progression-free Survival based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects
Time Frame	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description:	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description:	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
Overall Number of Participants Analyzed	239	239
Median (95% Confidence Interval) Unit of Measure: months
	2.79 (1.94 to 3.78)	1.91 (1.87 to 2.10)

3.Secondary Outcome


Title	Overall Survival in ESR1-mut Subjects
Description	Overall Survival in ESR1-mut subjects, where Overall Survival is defin...
Description	Overall Survival in ESR1-mut subjects, where Overall Survival is defined as the length of time from randomization until the date of death from any cause
Time Frame	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description:	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description:	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
Overall Number of Participants Analyzed	115	113
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (18.60 to NA)	16.95 ^[1] (14.00 to NA)

[1]

NA=not calculable (insufficient number of participants with events)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Elacestrant, Standard of Care (SoC)
	Comments	The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6141
	Comments	The p-value was generated by using a two-sided stratified log-rank test.
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.894
	Confidence Interval	(2-Sided) 95% 0.577 to 1.386
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Overall Survival in All Subjects
Description	Overall Survival in All (ESR1-mut and ESR1-WT) Subjects
Description	Overall Survival in All (ESR1-mut and ESR1-WT) Subjects
Time Frame	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description:	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description:	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
Overall Number of Participants Analyzed	239	239
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (19.29 to NA)	NA ^[1] (15.80 to NA)

[1]

NA=not calculable (insufficient number of participants with events)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Elacestrant, Standard of Care (SoC)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0697
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value was generated by using a two-sided stratified log-rank test.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.742
	Confidence Interval	(2-Sided) 95% 0.536 to 1.025
	Estimation Comments	Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-mut-nd), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	All-Cause Mortality was assessed in the Intention-to-Treat Population (239, 239 participants), which consists of all randomized subjects. This is the primary population for Progression-Free Survival and Overall Survival analyses in the Outcome Measures. Adverse Events reporting reflects the Safety Population (237, 230 participants), which consists of all subjects who received at least 1 dose of study medication. Serious and Other Adverse Events were assessed in the Safety Population.

Arm/Group Title	Elacestrant	Standard of Care (SoC)
Arm/Group Description	Subjects in Arm 1 will receive elac...	Subjects in Arm 2 will receive Inve...
Arm/Group Description	Subjects in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing	Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule
All-Cause Mortality
	Elacestrant	Standard of Care (SoC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	70/239 (29.29%)	80/239 (33.47%)
Serious Adverse Events Serious Adverse Events
	Elacestrant	Standard of Care (SoC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	29/237 (12.24%)	25/230 (10.87%)
Blood and lymphatic system disorders
Antiphospholipid syndrome ^† 1	1/237 (0.42%)	0/230 (0.00%)
Cardiac disorders
Cardiac arrest ^† 1	1/237 (0.42%)	0/230 (0.00%)
Angina pectoris ^† 1	0/237 (0.00%)	1/230 (0.43%)
Arrhythmia ^† 1	0/237 (0.00%)	1/230 (0.43%)
Myocardial infarction ^† 1	0/237 (0.00%)	1/230 (0.43%)
Gastrointestinal disorders
Nausea ^† 1	3/237 (1.27%)	0/230 (0.00%)
Vomiting ^† 1	2/237 (0.84%)	0/230 (0.00%)
Small intestinal obstruction ^† 1	2/237 (0.84%)	0/230 (0.00%)
Abdominal pain ^† 1	0/237 (0.00%)	2/230 (0.87%)
Colitis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Diarrhoea ^† 1	0/237 (0.00%)	1/230 (0.43%)
Enteritis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Ileus ^† 1	0/237 (0.00%)	1/230 (0.43%)
Intestinal ischaemia ^† 1	1/237 (0.42%)	0/230 (0.00%)
General disorders
General physical health deterioration ^† 1	1/237 (0.42%)	1/230 (0.43%)
Pyrexia ^† 1	1/237 (0.42%)	0/230 (0.00%)
Asthenia ^† 1	1/237 (0.42%)	0/230 (0.00%)
Mucosal inflammation ^† 1	1/237 (0.42%)	0/230 (0.00%)
Gait disturbance ^† 1	0/237 (0.00%)	1/230 (0.43%)
Hepatobiliary disorders
Cholecystitis acute ^† 1	1/237 (0.42%)	0/230 (0.00%)
Infections and infestations
Diverticulitis ^† 1	1/237 (0.42%)	1/230 (0.43%)
Pneumonia ^† 1	1/237 (0.42%)	3/230 (1.30%)
Septic shock ^† 1	1/237 (0.42%)	0/230 (0.00%)
COVID-19 ^† 1	0/237 (0.00%)	1/230 (0.43%)
Device related sepsis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Sepsis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Urinary tract infection ^† 1	0/237 (0.00%)	2/230 (0.87%)
Injury, poisoning and procedural complications
Femoral neck fracture ^† 1	1/237 (0.42%)	0/230 (0.00%)
Road traffic accident ^† 1	1/237 (0.42%)	0/230 (0.00%)
Investigations
Blood bilirubin increased ^† 1	1/237 (0.42%)	0/230 (0.00%)
Neutrophil count decreased ^† 1	0/237 (0.00%)	1/230 (0.43%)
Platelet count decreased ^† 1	0/237 (0.00%)	1/230 (0.43%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/237 (0.42%)	0/230 (0.00%)
Dehydration ^† 1	1/237 (0.42%)	0/230 (0.00%)
Electrolyte imbalance ^† 1	1/237 (0.42%)	0/230 (0.00%)
Hypercalcaemia ^† 1	1/237 (0.42%)	1/230 (0.43%)
Hypokalaemia ^† 1	0/237 (0.00%)	1/230 (0.43%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	2/237 (0.84%)	0/230 (0.00%)
Bone pain ^† 1	1/237 (0.42%)	0/230 (0.00%)
Pain in extremity ^† 1	1/237 (0.42%)	0/230 (0.00%)
Pathological fracture ^† 1	1/237 (0.42%)	1/230 (0.43%)
Arthritis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura ^† 1	0/237 (0.00%)	1/230 (0.43%)
Tumour pain ^† 1	0/237 (0.00%)	1/230 (0.43%)
Nervous system disorders
Spinal cord compression ^† 1	2/237 (0.84%)	0/230 (0.00%)
Headache ^† 1	1/237 (0.42%)	0/230 (0.00%)
Nervous system disorder ^† 1	1/237 (0.42%)	0/230 (0.00%)
Cerebrovascular accident ^† 1	0/237 (0.00%)	1/230 (0.43%)
Cranial nerve paralysis ^† 1	0/237 (0.00%)	1/230 (0.43%)
Dysarthria ^† 1	0/237 (0.00%)	1/230 (0.43%)
Ischaemic stroke ^† 1	0/237 (0.00%)	1/230 (0.43%)
Meningeal disorder ^† 1	0/237 (0.00%)	1/230 (0.43%)
Seizure ^† 1	0/237 (0.00%)	1/230 (0.43%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/237 (0.42%)	0/230 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/237 (0.42%)	0/230 (0.00%)
Lung disorder ^† 1	1/237 (0.42%)	0/230 (0.00%)
Pleural effusion ^† 1	1/237 (0.42%)	0/230 (0.00%)
Pulmonary embolism ^† 1	1/237 (0.42%)	1/230 (0.43%)
1 Term from vocabulary, MedDRA version 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Elacestrant	Standard of Care (SoC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	218/237 (91.98%)	198/230 (86.09%)
Blood and lymphatic system disorders
Anaemia ^† 1	22/237 (9.28%)	17/230 (7.39%)
Lymphocyte count decreased ^† 1	12/237 (5.06%)	5/230 (2.17%)
Gastrointestinal disorders
Nausea ^† 1	83/237 (35.02%)	44/230 (19.13%)
Vomiting ^† 1	45/237 (18.99%)	20/230 (8.70%)
Diarrhoea ^† 1	33/237 (13.92%)	23/230 (10.00%)
Constipation ^† 1	29/237 (12.24%)	15/230 (6.52%)
Dyspepsia ^† 1	24/237 (10.13%)	6/230 (2.61%)
Abdominal pain ^† 1	15/237 (6.33%)	14/230 (6.09%)
General disorders
Fatigue ^† 1	45/237 (18.99%)	44/230 (19.13%)
Asthenia ^† 1	22/237 (9.28%)	19/230 (8.26%)
Injection site pain ^† 1	0/237 (0.00%)	14/230 (6.09%)
Infections and infestations
Urinary tract infection ^† 1	16/237 (6.75%)	12/230 (5.22%)
Investigations
Aspartate aminotransferase increased ^† 1	31/237 (13.08%)	29/230 (12.61%)
Alanine aminotransferase increased ^† 1	22/237 (9.28%)	24/230 (10.43%)
Blood cholesterol increased ^† 1	16/237 (6.75%)	7/230 (3.04%)
Blood alkaline phosphatase increased ^† 1	15/237 (6.33%)	17/230 (7.39%)
Blood pressure Increased ^† 1	9/237 (3.80%)	12/230 (5.22%)
Blood glucose increased ^† 1	6/237 (2.53%)	12/230 (5.22%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	35/237 (14.77%)	22/230 (9.57%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	34/237 (14.35%)	37/230 (16.09%)
Back pain ^† 1	33/237 (13.92%)	22/230 (9.57%)
Musculoskeletal chest pain ^† 1	14/237 (5.91%)	7/230 (3.04%)
Musculoskeletal pain ^† 1	11/237 (4.64%)	13/230 (5.65%)
Myalgia ^† 1	11/237 (4.64%)	17/230 (7.39%)
Pain in extremity ^† 1	18/237 (7.59%)	14/230 (6.09%)
Bone pain ^† 1	15/237 (6.33%)	15/230 (6.52%)
Nervous system disorders
Headache ^† 1	29/237 (12.24%)	26/230 (11.30%)
Psychiatric disorders
Insomnia ^† 1	18/237 (7.59%)	11/230 (4.78%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	18/237 (7.59%)	16/230 (6.96%)
Cough ^† 1	15/237 (6.33%)	12/230 (5.22%)
Vascular disorders
Hot flush ^† 1	27/237 (11.39%)	19/230 (8.26%)
1 Term from vocabulary, MedDRA version 23.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Carlos A. Garay, MD, Senior Vice President, Clinical Development & Medical Affairs - Solid Tumors
Organization:	Stemline Therapeutics, Inc.
Phone:	877-332-7967
EMail:	clinicaltrials@menarinistemline.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3962.

Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.

Layout table for additonal information

Responsible Party:	Stemline Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT03778931
Other Study ID Numbers:	RAD1901-308
First Submitted:	December 3, 2018
First Posted:	December 19, 2018
Results First Submitted:	March 20, 2023
Results First Posted:	December 5, 2023
Last Update Posted:	March 29, 2024

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