18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free SurvivalPrimary· Randomization until progression of disease or death due to any cause up to 13 months (The study terminated prematurely) . The primary analysis was planned to be initiated when 58 PFS events have occurred
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v1.1 or death from any cause, whichever comes first as assessed by the investigator.
The tumor assessment (i.e., scan dates) was used for progression/censor date not the date corresponding to the determination of overall response. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
1
Arm B (Control): Placebo and Fulvestrant
1
Overall SurvivalSecondary· Randomization until death due to any cause up to 13 months (The study terminated prematurely)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The study was terminated on 30 Nov 2018 . Data represents outcomes up to 150 days of treatment.
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
1
Arm B (Control): Placebo and Fulvestrant
1
Time to ProgressionSecondary· Randomization to date of objective tumor progression up to 13 months (The study terminated prematurely)
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression.
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
52
33.25 – 72.25
Arm B (Control): Placebo and Fulvestrant
48
34.50 – 58.50
Number of Participants With Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant AloneSecondary· TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration.
Patients with any TEAE-Related
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
7
Arm B (Control): Placebo and Fulvestrant
4
Patients with any TEAE-Serious Adverse event
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
1
Arm B (Control): Placebo and Fulvestrant
0
NCI-CTCAE Grade 3 or Higher
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
2
Arm B (Control): Placebo and Fulvestrant
1
Percentage of Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant AloneSecondary· TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration.
TEAE-Related
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
63.6
Arm B (Control): Placebo and Fulvestrant
36.4
TEAE-Serious Adverse event
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
9.1
Arm B (Control): Placebo and Fulvestrant
0
NCI-CTCAE Grade 3 or Higher
Group
Value
95% CI
Arm A (Experimental): Seribantumab and Fulvestrant
18.2
Arm B (Control): Placebo and Fulvestrant
9.1
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline through to premature study completion up to 13 months (30 Nov 2018).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (Experimental): Seribantumab and Fulvestrant
This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc
· NA
· recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated,
· recruiting
Other Elevation Oncology trials
Trials by the same sponsor.
NCT05980416 — Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
· Phase 1
· terminated
NCT04383210 — Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
· Phase 2
· terminated
NCT02387216 — A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Elevation Oncology
Last refreshed: 2 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03241810.