Condition category
Cancer
Date applied
12/05/2014
Date assigned
30/05/2014
Last edited
31/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 below 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 measures

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

30/10/2016

Reason abandoned

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

30/06/2016

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

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Medicine and Health Faculty Office
University of Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 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.