Clinical Trials

Overview

Low-risk ductal carcinoma in situ (DCIS) lesions often do not progress to invasive breast cancer during the patient’s lifetime. Therefore, active surveillance without surgery as a management strategy for low-risk DCIS is being evaluated in three Randomized Controlled Clinical Trials (RCT), called the COMET (USA)- LORIS (UK)- and LORD (The Netherlands)-trial. These trials will compare standard treatment with active surveillance in approximately 3000 women aged ⩾ 40 years, asymptomatic, screen-detected low-risk DCIS, based on biopsies of calcifications. Both study arms will be monitored with digital mammography for a period of at least 10 years. The design of these trials are mostly comparable with some subtle differences. For example the LORIS-trial has a central histopathology review

process in which two pathologist review all diagnostic slides from patients registered with the study to confirm low-risk DCIS. The COMET and LORD-trial do not have such a review board. COMET performs mammography twice a year on patients randomized to active surveillance (annually for those randomized to standard treatment), whereas LORIS and LORD perform mammography annually on patients. While the COMET and LORIS trials allow endocrine treatment in both arms; LORD does not administer endocrine treatment. In summary, these trials are similar with regards to study population, design, and primary outcome. At the same time, the national differences in DCIS diagnosis, treatment and surveillance policy across the three countries present an excellent opportunity to discover insights regarding the DCIS dilemma.

The 3 clinical trials embedded in PRECISION – LORIS, LORD and COMET

 

LORIS

COMET

LORD

Country

UK

US

Netherlands/Europe

Age

>48

>40

>45

Standards of care

Standard local care

Guideline concordant

Standard local care

Endocrine therapy

No

Possible

No

Time to Primary Endpoint

5 years

2, 5, 7, 10

10

Opened

2014

2017

2017

Sites open

60/63

80/100

28

Patients

139

253

33

Accrual Target

188

1200 (900)

1240

Summary of RCT for Low Risk DCIS

Goals for the next 12 months

– Continue to improve recruitment strategies for all RCT

– Continue efforts to collect tissue, blood, imaging for correlative studies

– Ensure close monitoring of PRO completion

Useful Links:

What is DCIS?

Dr. Shelley Hwang and Patient Advocate Donna Pinto share perspectives:

https://www.youtube.com/watch?time_continue=9&v=Sh61r1bkR1Y

Educational resources

For DCIS patients:

https://dcisoptions.org/resources

For Physicians/Researchers:

https://dcisoptions.org/resources/researchers

 

LORIS mascot Boris, assisting with histopathology!