Contact information
Type
Scientific
Primary contact
Prof David Cameron
ORCID ID
Contact details
c/o Clinical Trials Research Unit
Leeds Institute of Clinical Research
Leeds
LS2 9JT
United Kingdom
-
lotus@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An international multi-centre long-term follow-up study of the long-term outcomes and impact of cancer treatments in 'triple-negative' breast cancer
Acronym
LOTUS
Study hypothesis
The LOTUS study aims to collect valuable information on the long-term effects and the impact of cancer treatments for patients with triple-negative breast cancer (TNBC).
Ethics approval
NRES Committee South West – Central Bristol, 21/11/2014, REC ref: 14/SW/1163, IRAS project ID: 158206
Study design
International observational non-CTIMP long-term follow-up study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Triple-negative breast cancer
Intervention
No medicinal products (investigational or non-investigational) are being administered as part of this protocol.
Ten years after the participant entered the BEATRICE trial, a hospital visit will take place which will include measuring blood pressure and a heart scan to test heart function.
Intervention type
Drug
Phase
Not Applicable
Drug names
Avastin
Primary outcome measure
1. The rate of disease-free survival at 10 years post-randomisation to the BEATRICE trial
2. The point prevalence of severe cardiac events at 10 years post-randomisation to the BEATRICE trial
Secondary outcome measures
Breast cancer endpoints:
1. Overall survival and cause of death at 10 years post-BEATRICE randomisation
2. Invasive disease-free survival at 10 years post-BEATRICE randomisation
3. Distant disease-free survival at 10 years post-BEATRICE randomisation
4. Overall survival and cause of death at 15 years post-BEATRICE randomisation
Cardiovascular endpoints:
1. The point prevalence by severity of cardiac morbidity, vascular events, cardiovascular risk factors and thyroid dysfunction at 10 years post-BEATRICE randomisation
2. The cumulative incidence of cardiac morbidity, vascular events, cardiovascular risk factors and thyroid dysfunction between entry into LOTUS and 10 years post-BEATRICE randomisation
Other endpoints:
1. The cumulative incidence of secondary primary malignancies at 10 years post-BEATRICE randomisation
2. The cumulative incidence of myelodysplasia at 10 years post-BEATRICE randomisation
3. The cumulative incidence of osteoporosis at 10 years post-BEATRICE randomisation
4. The cumulative incidence of reproductive health issues at 10 years post-BEATRICE randomisation
Overall trial start date
01/07/2014
Overall trial end date
01/03/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participated in the BEATRICE trial
2. Aged 18 or over
3. Currently being followed up at a site participating in the LOTUS study
4. Able to provide informed consent and comply with the trial schedule
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 250-500 participants
Participant exclusion criteria
1. Withdrawn from follow up from the BEATRICE trial
2. Given adjuvant endocrine therapy after completion of adjuvant chemotherapy
Recruitment start date
30/10/2014
Recruitment end date
03/01/2017
Locations
Countries of recruitment
Australia, Austria, Brazil, Canada, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, South, New Zealand, Philippines, Poland, Spain, Taiwan, Thailand, United Kingdom
Trial participating centre
Leeds Institute of Clinical Research
Leeds
LS2 9JT
United Kingdom
Funders
Funder type
Industry
Funder name
F. Hoffman-La Roche
Alternative name(s)
Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list