PROACT PLUS Registry and Echo Sub-study: Can we detect early chemotherapy-related heart damage?

PROACT PLUS Registry and Echocardiographic sub-study: an observational, prospective, cohort study assessing the use of novel echocardiographic tools and measurement of troponin to help detect early signs of cardiotoxicity in patients treated for breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11676341

Enrollment

Registered

2018-05-13

Start date

2018-06-01

Completion date

Unknown

Last updated

2022-08-05

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

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

PROACT PLUS registry and echo-substudy is a multicentre, observational, prospective cohort study assessing the use of novel echocardiographic tools and measurement of troponin to help detect early sig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients with a new diagnosis of histopathologically confirmed breast carcinoma 2. Age = 18 3. Planned to receive anthracycline based treatment (adjuvant or neoadjuvant) – any dose 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Meets eligibility criteria for the PROACT trial* 2. Known metastatic breast cancer *Patients who are otherwise eligible for the PROACT trial will not be eligible to participate in the PROACT registry

Design outcomes

Primary

Measure	Time frame
The presence (=14ng/L) or absence of cardiac troponin T (<14ng/L) release at any time during anthracycline treatment, 1 month and 12 months after the last dose of anthracycline: 1. Cardiac troponin I release during, 1 month and 12 months after the last dose of anthracyclines 2. Cardiac function assessed by echocardiogram, including GLS, measurement of LVEF, and measurement of novel echocardiographic strain parameters (namely: Global Radial Strain (GRS), Global Circumferential Strain (GCS), torsion and twist, Right Ventricular Free Wall (RVFW), left and right atrial strain), at baseline, 4 weeks following completion of chemotherapy and at 12 months	—

Measure

Time frame

The presence (=14ng/L) or absence of cardiac troponin T (<14ng/L) release at any time during anthracycline treatment, 1 month and 12 months after the last dose of anthracycline: 1. Cardiac troponin I release during, 1 month and 12 months after the last dose of anthracyclines 2. Cardiac function assessed by echocardiogram, including GLS, measurement of LVEF, and measurement of novel echocardiographic strain parameters (namely: Global Radial Strain (GRS), Global Circumferential Strain (GCS), torsion and twist, Right Ventricular Free Wall (RVFW), left and right atrial strain), at baseline, 4 weeks following completion of chemotherapy and at 12 months

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026