Studieoverzicht - 2014-04 LORD

 
Number 2014-04 LORD
Nickname LORD
Status Open Date: 10-02-2017
Inclusion closed
Other study number(s) EORTC 1401-BCG
Participating parties/groups EORTC
Full title Management of low grade ductal carcinoma in situ: active surveillance or not? A randomized, non-inferiority phase III trial
Phase and type Randomized Phase III
Age Women of age > or = 45 years old
Menopausal status Both pre- and postmenopausal
Indication Locoregional
Subindication Not applicable
Target sample size 1240
Actual accrual 20 Date: 09-07-2018
Estimated study completion date 01-02-2020
CCMO approval Not applicable Date: Nr: NL55612.031.16
EudraCT nr. Not applicable
Trial Register NCT02492607
METC approval Yes Date: 11-01-2017 METC: Nederlands Kanker Instituut Nr: E1401
Amendments Date: 15-06-2018
KWF-CKS approval Yes Date: 26-06-2015 Nr: NKI 2015-7711
News item
Website
Sponsor NKI
Principal Investigator(s) dr. J. Wesseling (NKI-AvL)
Study manager C. Sondermeijer (Clinical project manager NKI)
D. Straub (studiecoördinator BOOG)
Central datamanagement and randomization NKI-AVL
ALEA randomization
k.pengel@nki.nl
+31 (0) 20 512 2618
Monitoring Not applicable
Local datamanagement IKNL
Funding Logos KWF Alpe dHuzes en Pink Ribbon.png.jpg
Extra

Design:

This is a phase III, open-label, non-inferiority, multi-center, randomized clinical trial to compare the active surveillance with standard treatment approach (conventional arm) in patients with low- grade DCIS.

 

Objectives:

Primary objective:

To determine whether low-grade DCIS can be safely managed (measured by ipsilateral invasive breast cancer-free rate at 10 years) by an active surveillance strategy or that the standard treatment, being either wide local excision (WLE) only, WLE plus radiotherapy or mastectomy, possibly followed by hormonal therapy, will remain the standard of care.

Endpoints:

Primary end-point:
Ipsilateral invasive breast cancer-free rate at 10 years.

 

Secondary end-points:

♦ Rate of invasive disease at the final pathology specimen (standard arm only).

♦ Rate of grade II/III DCIS at the final pathology specimen (standard arm only).

♦ Biopsy rate for ipsilateral breast during follow-up (both therapeutic policies).

♦ Mastectomy rate for ipsilateral breast (baseline or subsequent ipsilateral DCIS or iBC) (both therapeutic policies).

♦ Time to ipsilateral DCIS grade II- III (both therapeutic policies).

♦ Time to contralateral DCIS grade I-II-III (both therapeutic policies).

♦ Time to contralateral invasive breast cancer (both therapeutic policies).

♦ Type of first event for primary endpoint (both therapeutic policies).

♦ Distant metastases free interval (distant metastases and death due to breast cancer as events) (both therapeutic policies).

♦ Overall survival (both therapeutic policies).

♦ Time to failure of active surveillance strategy (time to crossover to conventional therapy, due to any cause) 

♦ Quality of life (both therapeutic policies).

♦ Cost-effectiveness (both therapeutic policies).

 

Main eligibility criteria:

Written informed consent according to ICH/GCP, and national/local regulations

Women ≥ 45 years old, any menopausal status

Unilateral DCIS of any size 

American Society of Anesthesiologists (ASA) score 1 or 2 (see Appendix E) 

Lesions of type 'calcifications only', detected by population-based or opportunistic screening mammography 

At least six 8-12 Gauge biopsies of the area with calcifications were taken within 12 weeks of detection; The biopsy specimen will be considered representative if calcifications are found in the radiologic specimen or at pathology examination of the biopsies, in case no radiologic specimen was performed 

In case of an extended lesion (> 5 cm): biopsies were taken from the center and the periphery of the lesion, or from two peripheral parts of the lesion 

In case of multiple lesions with calcifications biopsies have been taken from two, but not more, groups of calcifications 

Marker placement at biopsy site (s) in the breast 

FFPE tissue blocks from the biopsy and, if applicable, from the resection specimen, are available for translational research purposes. If no FFPE tissue blocks can be submitted, 10 unstained slides of 4-5 μm thickness from the lesion(s) are acceptable 

Good correlation between pathological and radiological findings i.e. both findings confirm low-grade DCIS and no suspicion of intermediate or high- grade DCIS or invasive breast cancer 

The interval between histologic diagnosis of low-grade DCIS on biopsy and randomization is ≤ 12 weeks 

Documents (public):

Filmpje over DCIS

Documents (protected):
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