LOTUS: LOng-Term follow-Up Study of triple-negative breast cancer
ISRCTN | ISRCTN43423520 |
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DOI | https://doi.org/10.1186/ISRCTN43423520 |
Secondary identifying numbers | N/A |
- Submission date
- 12/05/2014
- Registration date
- 30/05/2014
- Last edited
- 30/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
c/o Clinical Trials Research Unit
Leeds Institute of Clinical Research
Leeds
LS2 9JT
United Kingdom
lotus@leeds.ac.uk |
Study information
Study design | International observational non-CTIMP long-term follow-up study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
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 |
Study acronym | LOTUS |
Study objectives | 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(s) | NRES Committee South West – Central Bristol, 21/11/2014, REC ref: 14/SW/1163, IRAS project ID: 158206 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2014 |
Completion date | 01/04/2025 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Approximately 250-500 participants |
Total final enrolment | 226 |
Key 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 |
Key exclusion criteria | 1. Withdrawn from follow up from the BEATRICE trial 2. Given adjuvant endocrine therapy after completion of adjuvant chemotherapy |
Date of first enrolment | 30/10/2014 |
Date of final enrolment | 03/01/2017 |
Locations
Countries of recruitment
- Australia
- Austria
- Brazil
- Canada
- England
- France
- Germany
- Hong Kong
- Israel
- Italy
- Japan
- Korea, South
- New Zealand
- Philippines
- Poland
- Spain
- Taiwan
- Thailand
- United Kingdom
Study participating centre
LS2 9JT
United Kingdom
Sponsor information
University/education
Medicine and Health Faculty Office
University of Leeds
Leeds
LS2 9JT
England
United Kingdom
https://ror.org/024mrxd33 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/06/2025: The following changes were made to the trial record:
1. The overall end date was changed from 01/03/2025 to 01/04/2025.
2. The total final enrolment was added.
03/10/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2016 to 03/01/2017.
2. The overall trial end date was changed from 30/10/2016 to 01/03/2025.
31/03/2016: The following changes were made to the trial record:
1. Ethics approval information added.
2. The overall trial end date was changed from 30/06/2016 to 30/10/2016.