The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
CompletedPhase 2Results postedLast updated 24 February 2025
What this trial tests
Phase 2 trial testing Xentuzumab in Breast Neoplasms in 103 participants. Completed in 11 May 2022.
18 and older, female only, with Breast Neoplasms. 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 Survival (PFS)Primary· From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.
Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions.
Overall Survival (OS)Secondary· From randomisation until death from any cause, up to 995 days.
Overall survival (OS) defined as the time from randomisation until death from any cause. For patients with 'event' as an outcome for OS:
OS\[days\] = date of outcome - date of randomisation + 1.
For patients with 'censored' as an outcome for OS:
OS (censored)\[days\] = date of outcome - date of randomisation + 1.
Number of Patients With Disease Control (DC)Secondary· From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
Disease control (DC) was defined as a best overall response (BOR) of either complete response (CR), partial response (PR), stable disease (SD) or Non-CR/No-PD. SD and Non-CR/Non-PR must have been observed up until at least week 24 tumor assessment. BOR was defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) based on all evaluable tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, t
Duration of Disease Control (DC)Secondary· From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
Duration of disease control (DC), defined as the time from randomisation until the earliest of disease progression (according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment) or death from any cause, among patients with DC. Duration of DC was assessed by independent reviewers.
The duration of DC was calculated as followed:
For patients with disease progression or death:
Duration of DC \[days\] = date of outcome - date of randomisation + 1
For patients without disease progression or death:
D
Number of Participants With Objective Response (OR)Secondary· From randomisation until end of treatment, up to 892 days.
Number of participants with objective response (OR) by independent assessment. OR is defined as a best overall response of complete response (CR) or partial response (PR). Best overall response is defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) and will consider all tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses asses
Time to Pain Progression or Intensification of Pain PalliationSecondary· From randomisation until the earliest of pain progression, intensification of pain palliation, death or the time point of progression free survival analysis, up to 843 days.
Time to pain progression or intensification of pain palliation was defined as the time from randomisation until the earliest of:
* 2 point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF), Item 3 (worst pain), without a decrease (of ≥1 point) from baseline analgesics use (via the 8-point Analgesic Quantification Algorithm \[AQA\]), or
* 2 point increase from baseline in the AQA, or Death.
Time frame: [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05110495 — IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy
· EARLY_PHASE1
· completed
NCT03099174 — This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combinat
· Phase 1
· completed
NCT02191891 — Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung
· Phase 1
· completed
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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 Boehringer Ingelheim
Last refreshed: 24 February 2025
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/NCT03659136.