Management of Low-risk DCIS (LORD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02492607|
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : March 8, 2019
A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns slow-growing low-risk DCIS (grade I and II). This implies that many women might be unnecessarily going through intensive treatment resulting in a decrease in quality of life and an increase in health care costs, without any survival benefit.
The LORD (LOw Risk DCIS) study is a randomized, international, multicenter, phase III non-inferiority trial, and aims to determine whether screen-detected low-risk DCIS can safely be managed by an active surveillance strategy or that the conventional treatment, being either WLE alone, WLE + RT, or mastectomy, and possibly HT, should remain the standard of care.
|Condition or disease||Intervention/treatment||Phase|
|DCIS||Other: Standard treatment Device: digital mammography Radiation: radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Management of Low Risk Ductal Carcinoma in Situ (Low-risk DCIS): a Randomized, Multicentre, Non-inferiority Trial, Between Standard Therapy Approach Versus Active Surveillance|
|Actual Study Start Date :||February 13, 2017|
|Estimated Primary Completion Date :||December 2029|
|Estimated Study Completion Date :||December 2029|
Active Comparator: Standard treatment
Standard treatment according to local policy. This can be either wide local excision only, wide local excision and radiotherapy, or mastectomy. Hormonal therapy is also allowed.
Other: Standard treatment
wide local excision only or wide local excision and radiotherapy or mastectomy.
+/- hormonal therapy
according local policy
Experimental: Active surveillance
Active surveillance : monitoring by annual digital mammography for a period of 10 years
Device: digital mammography
Other Name: Active surveillance
- Ipsilateral invasive breast cancer-free rate at 10 years [ Time Frame: 10 years from randomization ]
- Time to ipsilateral grade III DCIS [ Time Frame: from randomization to the development of a new ipsilateral DCIS, up to 10 years ]
- Time to contralateral DCIS [ Time Frame: from randomization to the development of a new contralateral DCIS, up to 10 years ]
- Time to contralateral invasive breast cancer [ Time Frame: from randomization to the development of a contralateral invasive breast cancer, up to 10 years ]
- Time to failure of active surveillance strategy [ Time Frame: from randomization to the time to patients received standard treatment, up to 10 years ]
- Distant metastases free interval [ Time Frame: from randomization to the time of invasive distant metastases or death due to breast cancer, up to 10 years ]
- Overall survival [ Time Frame: from randomization to the time of death, during 10 years at minimum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492607
|Contact: Sena Alaeikhanehshir, PhD student||+31 20512 ext email@example.com|
|Contact: Carine Sondermeijer, Bsc||+31 20512 ext firstname.lastname@example.org|
|Study Chair:||Jelle Wesseling, PhD||The Netherlands Cancer Institute|