LOTUS: LOng-Term follow-Up Study of triple-negative breast cancer

ISRCTN ISRCTN43423520
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-the-long-term-outcomes-and-impact-of-treatment-for-triple-negative-breast-cancer-lotus

Study website

Contact information

Prof David Cameron
Scientific

c/o Clinical Trials Research Unit
Leeds Institute of Clinical Research
Leeds
LS2 9JT
United Kingdom

lotus@leeds.ac.uk

Study information

Study designInternational observational non-CTIMP long-term follow-up study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleAn international multi-centre long-term follow-up study of the long-term outcomes and impact of cancer treatments in 'triple-negative' breast cancer
Study acronymLOTUS
Study objectivesThe 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) studiedTriple-negative breast cancer
InterventionNo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Avastin
Primary outcome measure1. 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 measuresBreast 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 date01/07/2014
Completion date01/04/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participantsApproximately 250-500 participants
Total final enrolment226
Key inclusion criteria1. 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 criteria1. Withdrawn from follow up from the BEATRICE trial
2. Given adjuvant endocrine therapy after completion of adjuvant chemotherapy
Date of first enrolment30/10/2014
Date of final enrolment03/01/2017

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

Leeds Institute of Clinical Research
Leeds
LS2 9JT
United Kingdom

Sponsor information

Funders

Funder type

Industry

F. Hoffman-La Roche
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.

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