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Management of Low-risk DCIS (LORD)

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ClinicalTrials.gov Identifier: NCT02492607
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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


Radiation: radiotherapy
according local policy

Experimental: Active surveillance
Active surveillance : monitoring by annual digital mammography for a period of 10 years
Device: digital mammography
annual mammography
Other Name: Active surveillance




Primary Outcome Measures :
  1. Ipsilateral invasive breast cancer-free rate at 10 years [ Time Frame: 10 years from randomization ]

Secondary Outcome Measures :
  1. Time to ipsilateral grade III DCIS [ Time Frame: from randomization to the development of a new ipsilateral DCIS, up to 10 years ]
  2. Time to contralateral DCIS [ Time Frame: from randomization to the development of a new contralateral DCIS, up to 10 years ]
  3. Time to contralateral invasive breast cancer [ Time Frame: from randomization to the development of a contralateral invasive breast cancer, up to 10 years ]
  4. Time to failure of active surveillance strategy [ Time Frame: from randomization to the time to patients received standard treatment, up to 10 years ]
  5. 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 ]
  6. Overall survival [ Time Frame: from randomization to the time of death, during 10 years at minimum ]


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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women of age > or = 45 years.
  • Any menopausal status.
  • Calcifications only lesions, detected by population-based or opportunistic screening mammography.
  • Within twelve weeks of detection at least six 12 G biopsies (or the equivalent of six 12 G needles) need to be taken from the area of the calcification. This implies at least 7 cc volume irrespective of supplier, or at least three 8G, four 9G, five 10G or five 11G biopsy needles need to be taken to meet LORD's eligibility criteria. Whatever needle size is applied, it is essential to confirm that the biopsies contain representative calcifications via biopsy radiography, microscopy, or both.
  • Any size DCIS.
  • Marker placement at biopsy site(s) in the breast.
  • Good correlation between pathological and radiological findings i.e. both findings confirm low-risk DCIS and no suspicion of high-grade DCIS or invasive breast cancer
  • Prior surgery of the ipsilateral breast because of a benign lesion allowed.
  • ASA score 1 or 2
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria:

  • Presence of mass, increased density around calcifications, architectural distortion, stellate lesion on mammography.
  • Presence of bilateral DCIS.
  • Presence of Paget's disease, invasive breast cancer, or pleomorphic LCIS
  • Presence of symptomatic DCIS e.g. DCIS detected by palpation or nipple discharge.
  • Presence of synchronous invasive carcinoma in the contralateral breast.
  • Prior history of invasive breast cancer or DCIS.
  • Prior history of other cancer except carcinoma in situ of the cervix or basocellular carcinoma of the skin.
  • Presence of serious disease that precludes definitive surgical treatment (e.g. cardiovascular/pulmonary/renal disease).
  • Individual with a family member with a known gene mutation associated with increased risk of breast cancer, unless study participant is a proven non-carrier of mutation
  • Presence of pregnancy or breast-feeding.
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Information from the National Library of Medicine

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


Contacts
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Contact: Sena Alaeikhanehshir, PhD student +31 20512 ext 7951 s.alaeikhanehshir@nki.nl
Contact: Carine Sondermeijer, Bsc +31 20512 ext 7423 c.sondermeijer@nki.nl

Locations
Show Show 42 study locations
Sponsors and Collaborators
The Netherlands Cancer Institute
Borstkanker Onderzoek Groep
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Jelle Wesseling, PhD The Netherlands Cancer Institute

Publications:
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02492607    
Other Study ID Numbers: M18LORD
2014-04 ( Other Identifier: BOOG )
EORTC-1401 ( Other Identifier: EORTC )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Women
DCIS grade I and II
Active surveillance
Standard treatment