LORD

Start date

Opened to recruitment 17-01-2017; New Patient Preference Trial Design opened to recruitment 01-07-2020

Sites open

48 sites open to recruitment

Trial website

NA

 

Story so far

The LORD Trial in the Netherlands is run by the Netherlands Cancer Institute (NKI) Amsterdam and EORTC. LORD trial is led by Prof. Dr. Jelle Wesseling, senior group leader (NKI) and Professor of breast pathology at Leiden University Medical Center (LUMC), Leiden, The Netherlands. So far, 28 sites have opened across the Netherlands and 33 patients have been randomized. In addition, 6 sites have opened in Belgium and approximately 15 more sites are set to open in other countries of Europe including France, Italy, Switzerland, Portugal, Germany, Denmark and Norway.
In February 2019, Grade II amendment was submitted and approved by ethical committee as were the renewed LORD quality of life questionnaires. An added bonus of the changes to the questionnaires is that they facilitate collaboration with the COMET/LORIS trial. Efforts are under way to set-up nation-wide liquid biopsy Biobank for blood sample collection from patients during the time of enrollment in the study and for annual follow ups thereafter.
LORD-researchers day was organized on 18 Feb 2019 which involved in depth discussion on accrual challenges from patient and professional perspective. Also the rationale about including grade II DCIS was discussed during these sessions. These sessions were attended by different clinicians from the different participating sites.

Since July 2020, the LORD study has a new design. The randomized trial has been altered into a Patient Preference Trial.
Due to the fact that most women who were asked for participating in the trial, refused to be randomized. These women had a preference for one of the two study arms. The accrual was dramatically low and increased already by 40% in a few months.

Sites open; 37 sites open to recruitment

  • So far, 37 sites have been opened across the Netherlands and 103 patients have been included.
  • In July 2020, the trial was transformed into a Patient preference trial. By evaluating the screening logs from the participating centers, we found that the majority of eligible women (75%) do not wish to be randomized. This is most likely due to the fact that women considered to be eligible for the trial are very well informed about the pro’s and cons of both arms, i.e. conventional treatment or active surveillance. As such, most women have already decided about their preferred DCIS management option , when they visit their surgeon or specialized nurse.
  • In addition, immunohistochemistry for the estrogen receptor and for HER2 is introduced to prevent high grade DCIS grade lesions to be included in the trial, as non-high grade DCIS appeared to be convincingly ER-positive in 100% of all cases and for about 90% HER2-negative, according to a recent international study (manuscript in preparation) .Therefore, performing immunohistochemistry for these two markers will further reduce the chances of including women high grade DCIS, thus adding an extra safeguard to the trial.

Current status

Open to recruitment

Patients recruited/accrual target

307; 234 since new design /2500

Challenges and opportunities

  • Willingness to consent by patient preference
  • Patient perspective versus professional perspective
  • Site activation