KOL Pulse — Trial Profile
EMERALD TrialER+/HER2- advanced or metastatic breast cancer with ESR1 mutation, after prior ET + CDK4/6 inhibitor — Menarini / Stemline Therapeutics (Radius Health co-developer)
ER+/HER2- advanced or metastatic breast cancer with ESR1 mutation, after prior ET + CDK4/6 inhibitor Orserdu SABCS 2021 primary / ASCO 2024 extended analyses ✓ FDA Approved (2023-01)
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Influence Leaders
Top KOLs Discussing EMERALD
Hope Rugo
@hoperugo
9.6K impressions
Oncology Brothers
@OncBrothers
4.5K impressions
Sara Tolaney
@stolaney1
3.7K impressions
Annals of Oncology
@Annals_Oncology
2.9K impressions
Kazuki Nozawa
@kazuki_nozawa
2.2K impressions
Nagi El Saghir MD, FASCO, FACP
@NagiSaghir
335 impressions
Conference Presentations
EMERALD Key Slides & Visuals
Official trial slides and relevant visuals shared by KOLs at SABCS 2021 primary / ASCO 2024 extended analyses. Click any image to expand.
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[Slide 1]
Study design
5
Primary endpoint
Patients with HER2+ LABC or MBC
Eribulin group (21-day cycle)
Progression-free survival
Eribulin 1.4 mg/m2
(PFS), investigator-assessed
Age 20-70 years
days 1, 8
No prior use of chemotherapy
+
Secondary endpoints
(excluding T-DM1) for LABC/MBC
H+ Pa day 1
Objective response rate
Hormonal or anti-HER2 therapy alone,
(ORR)
or their combination as treatment for
R
Duration of response
recurrence, were allowed
1:1
Overall survival (OS)
ECOG performance status score 0/1
Taxane group (21-day cycle)
Patient-reported outcomes
Left ventricular ejection fraction (LVEF)
(QoL and neuropathy)
>50%
Docetaxel 75 mg/m2 day 1 or
Major organ function preserved
Paclitaxel 80 mg/m2 days 1, 8, 15
Safety and biomarker
New metastases-free
+
At least 6 months since prior
survival
neoadjuvant or adjuvant cytotoxic
H+ Pa day 1
Duration of next treatment
chemotherapy
Translational research
Stratification factors for randomization
Search for biomarker to
History of perioperative use of taxane
improve individual precision
Prior treatment with HER2-targeting antibody-drug conjugate after recurrence
Presence of visceral metastases
therapy
"Trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg subsequent doses . pertuzumab (P): 840 mg/body loading dose, 420 mg/body subsequent doses
Treatment continued to disease progression or unmanageable toxicity
JBCRG-M06/EMERALD A multicenter, randomized, non-inferiority phase 3 trial
(UMIN000027938; ClinicalTrials.gov identifier, NCT03264547)
2024 ASCO
#ASCO24
PRESENTED am Toshinari Yamashita MD, PhD
ASCO
AMERICAN SOCIETY
CURICAL ORCOLOGY
ANNUAL MEETING
Presentation property author and ASCO Permission required for - contact permissore@ascs.org
KNOWLEDGE CONQUERS CANCER
---
[Slide 2]
PFS (primary endpoint)
11
Eribulin group: median, 14.0 (95% CI, 11.7-16.2) months
(%)
********
100
Taxane group: median, 12.9 (95% CI, 10.8-15.6) months
HR: 0.95 (95% CI, 0.76-1.19)
80
Log-rank test P = 0.6817
The primary endpoint results met the criterion for non-inferiority
Progression-free survival
(i.e. upper limit of 95% CI < 1.33)
60
The subsequent superiority test results showed no statistical
difference between the groups
40
20
0
0
6
12
18
24
30
36
42
48
54
60
66
72
No. risk
Months
Eribulin group
224
191
119
81
64
43
34
26
17
8
3
0
0
Taxane group
222
173
105
75
59
39
28
21
16
9
3
0
0
2024 ASCO
#ASCO24
PRESENTED am Toshinari Yamashita MD, PhD
ASCO
AMERICAN SOCIETY OF
CURICAL ONCOLOGY
ANNUAL MEETING
Presentation property author and ASCO Permission a -
KNOWLEDGE CONQUERS CANCER
2024 ASCO
---
[Slide 3]
15
OS
Eribulin group: median, not reached
(%)
*******
100
Taxane group: median, 65.3 months
HR: 1.09 (95% CI, 0.76-1.58)
Log-rank test p = 0.7258
80
Overall survival
60
40
is
20
0
0
6
12
18
24
30
36
42
48
54
60
66
72
Months
No. risk
Eribulin group
224
222
214
200
187
141
112
83
64
37
17
2
0
Taxane group
222
218
203
193
180
141
109
81
57
37
16
0
0
2024 ASCO
PRESENTED BY Toshinari Yamashita MD, PhD
ASCO
AMERICAN SOCIETY DE
#ASCO24
CLINICAL ONCOLOGY
ANNUAL MEETING
Presentation property the - and ABOO Permase required for - - permissors@asca.org
KNOWLEDGE CONQUERS CANCER
2024 ASCC
ANNUAL MEETIN
---
[Slide 4]
Drug-related treatment-emergent adverse events
17
Special interest
Eribulin group
Taxane group
All
93.3
58.9
59.2
96.3
Neutropenia
61.6
33.9
20.6
30.7
Grade >3 febrile neutropenia
4.9
8.7
Peripheral sensory neuropathy
61.2
9.8
4.1
52.8
1.8
0.5
Peripheral motor neuropathy
5.4
3.7
Skin-related events (incl. nail disorders)
40.6
1.3
4.6
62.4
Diarrhea
36.6
2.7
6.9
54.1
Edema
8.5
0.4
6.9
42.2
1.4
Cardiac events
7.1 0.4
6.0
100
80
60
40
20
0
20
40
60
80
100
Incidence (%)
All grades
Grade 23
All grades
Grade 23
2024 ASCO
#ASCO24
PRESENTED BY: an Toshinari Yamashita MD, PhD
ASCO
AMERICAN SOCIETY
CURICAL OHCOLOGY
ANNUAL MEETING
I
property
-
-
ABCO
Permission
required
for
I
contact
KNOWLEDGE CONQUERS CANCER
20
Click to expand
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[Slide 1]
Prior therapies
Eribulin group
Taxane group
All
(n 224)
(n=222)
in 446)
De novo stage 4
130 (58.0)
133 (59.9)
263 (59.0)
Recurrence/metastasis
94 (42.0)
89 (40.1)
183 (41.0)
Perioperative treatment
Chemotherapy
No
15(6.7)
16 (7.2)
31 (7.0)
Yes
79(35.3)
73 (32.9)
152 (34.1)
Anthracycline + taxane
57 (25.4)
50 (22.5)
107 (24.0)
Taxane only
14(63)
17 (7.7)
31 (7.0)
Anthracycline only
6(2.7)
5(23)
11 (2.5)
Other
2(0.9)
1 (0.5)
3 (0.7)
Anti-HER2 therapy
No
27(12.1)
22 (9.9)
49 (11.0)
Yes
67(29.9)
67 (30.2)
134 (30.0)
Trastuzumab only
63 (28.1)
63 (28.4)
126 (28.3)
Trastuzumab + pertuzumab
4 (18)
4 (1.8)
8 (1.8)
Treatment for recurrent disease
T-DM1
4(1)
6(2.7)
10 (2.2)
Anti-HER2 therapy only
209
5 (2.3)
7 (1.6)
Hormonal therapy only
22 (5)
11 (5.0)
33 (7.4)
Hormonal therapy . anti-HER2 therapy
7(3,1)
5 (2.3)
12 (2.7)
Values are expressed as 0 (%) *including one patient who received trastuzumab and T-MM stratification factors (revised) T-OM1 trastuzumab entansine
2024
ASCO
PRESENTED BY Toshinari Yamashita MD. PhD
ASCO
SOCIETY
#ASCO24
Guest CHOCOLOGY
ANNUAL MEETING
6800
KNOWLEDGE CONQUERS CANCER
---
[Slide 2]
Study design
Primary endpoint
Patients with HER2+ LABC or MBC
Eribulin group (21-day cycle)
Progression-free survival
Age 20-70 years
Eribulin 1.4 mg/m2
(PFS), investigator-assessed
days 1, 8
No prior use of chemotherapy
+
Secondary endpoints
(excluding T-DM1) for LABC/MBC
H . P* day 1
Objective response rate
Hormonal or anti-HER2 therapy alone,
(ORR)
or their combination as treatment for
R
Duration of response
recurrence, were allowed
1:1
Overall survival (OS)
ECOG performance status score 0/1
Taxane group (21-day cycle)
Patient-reported outcomes
Left ventricular ejection fraction (LVEF)
(QoL and neuropathy)
>50%
Docetaxel 75 mg/m2 day 1 or
Major organ function preserved
Pacitaxel 80 mg/m² days 1,8, 15
Safety and biomarker
+
New metastases-free
At least 6 months since prior
neoadjuvant or adjuvant cytotoxic
H+ Pa day 1
survival
Duration of next treatment
chemotherapy
Translational research
Stratification factors for randomization
Search for biomarker to
History of perioperative use of taxane
Prior treatment with HER2-targeting antibody-drug conjugate after recurrence
improve individual precision
Presence of visceral metastases
therapy
Trastuzumab (H) 8 mg/kg loading dose, 1mg autsequent doses perfuzumab (P): 840 mg/body loading dose, 420 mg/body subsequent doses
Treatment continued to disease progression - ummanageable toxicity
JBCRG-M06/EMERALD A multicenter, randomized, non-inferiority phase 3 trial
(UMIN000027938; ClinicalTrials gov identifier, NCT03264547)
2024 ASCO
#ASCO24
PRESENTED BY: Toshinan Yamashita MD, PhD
ASCO
- - -
CARRICAL SHICOLOGY
ANNUAL MEETING
- - the - - ABCD - - -
KNOWLEDGE CONQUERS CANCER
---
[Slide 3]
Prior therapies
5
Eribulin group
Taxane group
All
(n - 224)
(n - 222)
(n 446)
De novo stage 4
130 (58.0)
133 (59.9)
263 (59.0)
Recurrence / metastasis
94(42.0)
89 (40.1)
183 (41.0)
Perioperative treatment
Chemotherapy
No
15 (6.7)
16 (7.2)
31 (7.0)
Yes
79 (35.3)
73 (32.9)
152 (34.1)
Anthracycline + taxane
57 (25.4)
50 (22.5)
107 (24.0)
Taxane only
14 (6.3)
17 (7.7)
31 (7.0)
Anthracycline only
6(27)
5(2.3)
11 (2.5)
Other
2(0.9)
1 (0.5)
3 (0.7)
Anti-HER2 therapy
No
27 (121)
22 (9.9)
49 (11.0)
Yes
67 (29.9)
67 (30.2)
134(30.0)
Trastuzumab only*
53(28.1)
63 (28.4)
126 (28.3)
Trastuzumab . pertuzumab
4(1.8)
4(1.8)
6(1.8)
Treatment for recurrent disease
T-DM1
4(1)
6(2.7)
10 (2.2)
Anti-HER2 therapy only
2(09)
5(2.3)
7(1.6)
Hormonal therapy only
22(9)
11 (5.0)
33 (7.4)
Hormonal therapy . anti-HER2 therapy
7(3.1)
5(2.3)
12(2.7)
Values are expressed as n (%). including one patient who received trastuzumab and T-CM1 - stratification factors (revised). T-DM1, trastuzumab emtansine
2024 ASCO
PRESENTED am Toshinari Yamashita MD, PhD
#ASCO24
ASCO
- - society -
CURCK GREDADER
ANNUAL MEETING
- proper's - - and ABOO - - - -
KNOWLEDGE CONQUERS CANCER
---
[Slide 4]
PFS (primary endpoint)
11
(%)
Eribulin group: median, 14.0 (95% CI, 11.7-16.2) months
100
........
Taxane group: median, 12.9 (95% CI, 10.8-15.6) months
HR: 0.95 (95% Cl, 0.76-1.19)
80
Log-rank test P = 0.6817
The primary endpoint results met the criterion for non-inferiority
Progression-free survival
(i.e. upper limit of 95% CI < 1.33)
60
The subsequent superiority test results showed no statistical
difference between the groups
40
20
0
0
6
12
18
24
30
36
42
48
54
60
66
72
No. at risk
Months
Eribulin roup
224
191
119
81
64
43
34
26
17
8
3
0
0
axane group
222
173
105
75
59
39
28
E
16
9
3
0
0
2024 ASCO
#ASCO24
PRESENTED (If) Toshinari Yamashita MD, PhD
ASCO
- - agreem OF
ANNUAL MEETING
CIRICAL CHECKED
- property of - - and ABCO. - - -
KNOWLEDGE CONQUERS CANCER
Trial Background
About the EMERALD Trial
EMERALD established elacestrant (Orserdu) as the first oral SERD approved (January 27, 2023) for ESR1-mutated ER+/HER2- advanced/mBC after at least one line of ET. Benefit is strongest in patients with prior ET+CDK4/6i ≥12 months (mPFS 8.6 vs. 1.9 mo), supporting its role in endocrine-sensitive tumors that acquired ESR1 resistance. Real-world outcomes exceed trial efficacy. Competes with camizestrant (SERENA-6), imlunestrant (EMBER-3), and vepdegestrant (VERITAC-2) — the latter two both with pivotal 2024/2025 readouts. EMERALD's 12+ mo prior-CDK4/6i subgroup defines the ideal real-world use.
Regulatory Milestone
FDA Approval
FDA APPROVED Orserdu — Elacestrant (Orserdu) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. First oral SERD approved. (Stemline Therapeutics / Menarini)FDA approval date: 2023-01-27 .
📄 Source: FDA Press Release →
Study Design
Trial Methodology & Results
Progression-Free Survival (PFS) — Dual Primary Endpoint (ITT + ESR1-mutated)
Median: 3.8 months (elacestrant 345 mg daily) vs. 1.9 months (SOC endocrine therapy (AI or fulvestrant)). HR 0.55 (95% CI 0.39-0.77), P=0.0005 ESR1m + prior ET+CDK4/6i ≥12 mo rate: 8.6% (elacestrant) vs. 1.9% (SOC). In ESR1-mutated ER+/HER2- mBC: median PFS 3.8 months (elacestrant) vs. 1.9 months (SOC); HR 0.55 (95% CI 0.39-0.77, P=0.0005) — 45% reduction in risk of progression/death. Subgroup with prior ET+CDK4/6i ≥12 months (n=222): median PFS 8.6 vs. 1.9 months (HR 0.41, 95% CI 0.26-0.63). Overall population (N=478): mPFS 2.8 vs. 1.9 months (HR 0.70). Consistent benefit across subgroups (bone mets, liver/lung mets, ≥3 metastatic sites, PIK3CA mut, HER2-low, ESR1 variant D538G/Y537S/N). Bidard et al., JCO 2022.
✓ ESR1m mPFS 3.8 vs. 1.9 mo (HR 0.55, P=0.0005); ET+CDK4/6i ≥12mo: 8.6 vs. 1.9
📄 Source: KOL commentary on X →
Overall Survival (OS)
Overall survival data were immature at primary analysis and in subsequent updates. FDA approval (January 2023) was based on PFS benefit in ESR1m population. Patient-reported outcomes (PROs) from QLQ-C30, PRO-CTCAE, and EQ-5D-5L tools showed QoL was MAINTAINED between treatment groups with no clinically meaningful differences in adverse effects of interest (nausea, vomiting, fatigue, joint/muscle pain, hot flashes).
📄 Source →
Safety & Tolerability
Key AEs: nausea (most common with elacestrant), vomiting, fatigue, joint and muscle pain, hot flashes. Grade ≥3 TRAE rates per Bidard 2022 JCO: nausea Grade ≥3 was 2.5% (elacestrant). Overall manageable safety profile, oral once-daily dosing. Discontinuation rate low. No dose-limiting cardiac/hepatic signals. Full safety detailed in JCO 2022 primary publication.
✓ QoL maintained; manageable safety with oral once-daily dosing
📄 Source →
Clinical Implications ✅ FDA-approved (Jan 2023): first oral SERD for ESR1m ER+/HER2- advanced BC post-ET+CDK4/6i. EMERALD established elacestrant (Orserdu) as the first oral SERD approved (January 27, 2023) for ESR1-mutated ER+/HER2- advanced/mBC after at least one line of ET. Benefit is strongest in patients with prior ET+CDK4/6i ≥12 months (mPFS 8.6 vs. 1.9 mo), supporting its role in endocrine-sensitive tumors that acquired ESR1 resistance. Real-world outcomes exceed trial efficacy. Competes with camizestrant (SERENA-6), imlunestrant (EMBER-3), and vepdegestrant (VERITAC-2) — the latter two both with pivotal 2024/2025 readouts. EMERALD's 12+ mo prior-CDK4/6i subgroup defines the ideal real-world use.
Physician Opinions
Key KOL Sentiments — EMERALD
