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

An international multi-centre long-term follow-up study of the long-term outcomes and impact of cancer treatments in 'triple-negative' breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN43423520

Enrollment

500

Registered

2014-05-30

Start date

2014-10-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative breast cancer Cancer Breast cancer

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion 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

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 Withdrawn from follow up from the BEATRICE trial 2.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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026