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

ISRCTN	ISRCTN43423520
DOI	https://doi.org/10.1186/ISRCTN43423520
Protocol serial number	N/A
Sponsor	University of Leeds (UK)
Funder	F. Hoffman-La Roche

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

Contact information

Prof David Cameron
Scientific

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

Email	lotus@leeds.ac.uk

Study information

Primary study design	Observational
Study design	International observational non-CTIMP long-term follow-up study
Secondary study design	Cohort study
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Avastin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/04/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
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

United Kingdom
England
Australia
Austria
Brazil
Canada
France
Germany
Hong Kong
Israel
Italy
Japan
Korea, South
New Zealand
Philippines
Poland
Spain
Taiwan
Thailand

Study participating centre

Leeds Institute of Clinical Research

Leeds
LS2 9JT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.