Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03659136
Registration number
NCT03659136
Ethics application status
Date submitted
3/09/2018
Date registered
6/09/2018
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
Query!
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
Query!
Secondary ID [1]
0
0
2017-003131-11
Query!
Secondary ID [2]
0
0
1280-0022
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomisation until death from any cause, up to 995 days.
Query!
Secondary outcome [2]
0
0
Number of Patients With Disease Control (DC)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
Query!
Secondary outcome [3]
0
0
Duration of Disease Control (DC)
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.
Query!
Secondary outcome [4]
0
0
Number of Participants With Objective Response (OR)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From randomisation until end of treatment, up to 892 days.
Query!
Secondary outcome [5]
0
0
Time to Pain Progression or Intensification of Pain Palliation
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
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.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/11/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/05/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
103
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
The Tweed Hospital - Tweed Heads
Query!
Recruitment hospital [2]
0
0
Peninsula Haematology & Oncology - Frankston
Query!
Recruitment postcode(s) [1]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [2]
0
0
3199 - Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oklahoma
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Utah
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Bruxelles
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Jette
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Kortrijk
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Leuven
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Quebec
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Avignon
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Le Mans
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Marseille
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Paris
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Pierre Benite
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Toulouse
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Erlangen
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Karlsruhe
Query!
Country [28]
0
0
Greece
Query!
State/province [28]
0
0
Athens
Query!
Country [29]
0
0
Greece
Query!
State/province [29]
0
0
Heraklion
Query!
Country [30]
0
0
Greece
Query!
State/province [30]
0
0
Larisa
Query!
Country [31]
0
0
Greece
Query!
State/province [31]
0
0
Neo Faliro, Athens
Query!
Country [32]
0
0
Greece
Query!
State/province [32]
0
0
Thessaloniki
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Napoli
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Padova
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Roma
Query!
Country [36]
0
0
Portugal
Query!
State/province [36]
0
0
Lisboa
Query!
Country [37]
0
0
Portugal
Query!
State/province [37]
0
0
Loures
Query!
Country [38]
0
0
Portugal
Query!
State/province [38]
0
0
Vila Nova de Gaia
Query!
Country [39]
0
0
Spain
Query!
State/province [39]
0
0
A Coruña
Query!
Country [40]
0
0
Spain
Query!
State/province [40]
0
0
Barcelona
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
Lleida
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Madrid
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Málaga
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Valencia
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03659136
Query!
Trial related presentations / publications
Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Query!
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/36/NCT03659136/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT03659136/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03659136