PRECISION is funded by Cancer Research UK and Dutch Cancer Society
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 Clinical Trials, called the COMET (USA)- LORIS (UK)- and LORD (The Netherlands/EU)-trial. COMET and LORIS (closed to recruitment March 2020) are Randomized Clinical Trials (RCTs) whereas LORD changed design to Patient Preference Trial in July 2020. 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. The LORD trial introduces immunostaining of the estrogen receptor and HER2 to prevent high grade lesions to be included as non-high grade DCIS appeared to be convincingly ER-positive in 100% of all cases and for about 90% HER2-negative. In the LORD study , patients will be followed for five years annually and additionally, at year seven and year ten of follow-up. In summary, these trials are similar with regards to study population 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 (new design) | |
| Country | UK | US | Netherlands/Europe |
| Age | >46 | >40 | >45 |
| Standards of care | Standard local care | Surgery | Standard local care |
| Endocrine therapy | No | Possible | No |
| Time to Primary Endpoint | 5 years | 2, 5, 7, 10 | 10 |
| Opened | 2014 | 2017 | 2020 |
| Sites open | 60 | 84/100 | 48 |
| Patients | 181 | 700 | 307, 234 since new design |
| Blood Samples collected | 151 | 650 | 30 |
| Accrual Target | 188 | 1200 (900) | 2500 |
| Comments | Closed for recruitment 31st March 2020 | *LORD changed design to Patient Preference Trial from randomized one in Q2 2020 |
Summary of RCT for Low Risk DCIS (last updated 31st May 2021)
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!