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

• Register: ISRCTN
• Last refreshed on: 30 October 2017
• Main ID: ISRCTN43423520
• Date of registration: 30/05/2014
• Prospective Registration: Yes
• Primary sponsor: University of Leeds (UK)
• Public title: LOTUS: LOng-Term follow-Up Study of triple-negative breast cancer
• 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
• Date of first enrolment: 30/10/2014
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN43423520
• Study type: Observational
• Study design: International observational non-CTIMP long-term follow-up study (Treatment)
• Phase: Not Applicable

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

Contacts

• Name: David Cameron

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Withdrawn from follow up from the BEATRICE trial
2. Given adjuvant endocrine therapy after completion of adjuvant chemotherapy

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Triple-negative breast cancer
Cancer
Breast cancer

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

N/A

Source(s) of Monetary Support

F. Hoffman-La Roche