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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03659136
Registration number
NCT03659136
Ethics application status
Date submitted
3/09/2018
Date registered
6/09/2018
Date last updated
31/05/2023
Titles & IDs
Public title
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
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Scientific title
XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
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Secondary ID [1]
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2017-003131-11
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Secondary ID [2]
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1280-0022
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Xentuzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Everolimus
Treatment: Drugs - Exemestane
Experimental: Xentuzumab/everolimus/exemestane -
Placebo Comparator: Placebo/everolimus/exemestane -
Treatment: Drugs: Xentuzumab
Intravenous infusion
Treatment: Drugs: Placebo
Intravenous infusion
Treatment: Drugs: Everolimus
Tablet
Treatment: Drugs: Exemestane
Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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From randomisation until death from any cause, up to 995 days.
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Secondary outcome [2]
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Number of Patients With Disease Control (DC)
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Assessment method [2]
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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, tumor assessments after two or more consecutively misses assessments were not considered. DC was assessed by independent reviewers.
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Timepoint [2]
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From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
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Secondary outcome [3]
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Duration of Disease Control (DC)
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Assessment method [3]
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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:
Duration of DC (censored) [days] = date of outcome - date of randomisation + 1
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Timepoint [3]
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From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
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Secondary outcome [4]
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Number of Participants With Objective Response (OR)
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Assessment method [4]
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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 assessments were not considered.
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Timepoint [4]
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From randomisation until end of treatment, up to 892 days.
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Secondary outcome [5]
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Time to Pain Progression or Intensification of Pain Palliation
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Assessment method [5]
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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.
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Timepoint [5]
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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.
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Eligibility
Key inclusion criteria
- Documented histologically confirmed breast cancer with ERand/ or PgR-positive and
HER2-negative status
- Locally advanced or metastatic breast cancer not deemed amenable to curative surgery
or curative radiation therapy
- Archival tumour sample available at the time of informed consent and provided to the
central laboratory around the time of randomisation. Patients must provide a
formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the
time of presentation with recurrent or metastatic disease (provision of a biopsy
sample taken from the bone is not acceptable).
- Patients must satisfy the following criteria for prior therapy:
- Disease progression during treatment or within 12 months of completion of
endocrine adjuvant therapy or
- Disease progression while on or within 1 month after the end of prior endocrine
therapy for advanced/metastatic breast cancer (Note: the endocrine therapy does
not have to be the treatment immediately prior to trial entry).
- Patients must have
- At least one measurable non-visceral lesion according to RECIST version 1.1 in
either lymph nodes, soft tissue, skin and/or
- At least one measurable non-visceral lesion according to RECIST version 1.1 as
lytic or mixed (lytic + blastic) in bone and/or
- At least one non-measurable (lytic, mixed lytic + blastic, or blastic) bone
lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Fasting glucose <8.9 mmol/L (<160 mg/dL) and HbA1c <8.0%
- Adequate organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Previous treatment with agents targeting the IGF pathway, AKT, or mTOR pathways
- Prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior
to start of study treatment as long as the patient did not recur during or within 12
months after the end of adjuvant exemestane)
- Evidence of visceral metastasis/es (i.e. liver, lung, peritoneal, pleural metastases,
malignant pleural effusions, malignant peritoneal effusions) at screening. NOTE:
Patients with a past history of visceral metastases are eligible if visceral
metastases have completely resolved at least 3 months
- History or evidence of metastatic disease to the brain
- Leptomeningeal carcinomatosis
- More than 1 prior line of chemotherapy for HR+ HER2- metastatic breast cancer
- Radiotherapy within 4 weeks prior to the start of study treatment
- Use of concomitant systemic sex hormone therapy
- History or presence of cardiovascular abnormalities
- Known pre-existing interstitial lung disease
- Further exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/05/2022
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [2]
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Peninsula Haematology & Oncology - Frankston
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Recruitment postcode(s) [1]
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2485 - Tweed Heads
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Connecticut
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Florida
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Georgia
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Indiana
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Minnesota
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Missouri
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Oklahoma
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Washington
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Bruxelles
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Jette
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Avignon
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France
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Paris
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France
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Pierre Benite
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France
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Toulouse
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Germany
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Erlangen
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Germany
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Karlsruhe
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Neo Faliro, Athens
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Loures
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Barcelona
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Lleida
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03659136
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03659136
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