Tailored Screening for Breast Cancer in Premenopausal Women
NCT ID: NCT02619123
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33200 participants
INTERVENTIONAL
2013-01-31
2022-01-31
Brief Summary
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44-45 years old women will be enrolled and invited to undergo a digital mammography. Women are then randomly allocated in two arms. In the intervention arm, women will receive a tailored screening strategy according to breast density.
The aim of this study is to assess the impact of a longer screening interval and the reduction of side effects for premenopausal women.
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Detailed Description
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Methods 44- 45 years old women resident in the screening centre catchment area will be invited to attend for mammography screening and will be asked for informed consent in order to be included in the study. After the enrolment, they will receive a high quality digital mammography; two views and breast density will be classified according with the BI-RADS classification. Women are randomly allocated either to an usual care group or to the intervention group. In the intervention group, women with a dense breast (3-4 categories in BI-RADS) will be invited again after 1 year, while the lower-density group in the intervention arm will be invited after 2 years. After the age of 50, all women will continue to be screened in the usual service screening programme. Density of the breast will be read by 2 readers, and controversies will be solved by a consensus. Allocation of women is blinded to the mammography readers.
EXPECTED RESULTS: the outcomes are: 1. cumulative incidence of interval-cancer cases by intention to treat grouping and by density group, aimed at assessing the non inferiority of screening performance; 2. cumulative incidence of T2+/node-positive status breast cancer cases between arms and by protocol. Screening performance parameters will be evaluated at each screening round. Interim and outcome analysis are expected at 3 and 6 years average follow-up, respectively, starting from the beginning of the screening.
SAMPLE SIZE: the non-inferiority limit is derived from the accepted level of interval cancers in women 50-69 years, which was considered acceptable by the European Community Guidelines. Assuming a 70%BI-RADS 1-2 at the baseline on the basis of the digital mammography experience, the estimated sample size with a power of 90% is 16,596 women per arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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invitation to mammography screening
44-45 years old women in this arm are invited to attend for a mammography screening every 1 year. After the age of 50, all women will continue to be screened in the usual service screening programme.
Annual invitation to mammography
Annual interval mammography screening according to international guidelines for women younger than 50 years old
invitation to tailored screening
44-45 years old women in this arm with a dense breast (3-4 categories in BI-RADS) at the baseline mammography are invited again after 1 year, while the lower-density group in the intervention arm are invited after 2 years. After the age of 50, all women will continue to be screened in the usual service screening programme.
Tailored screening according to breast density
Different interval of mammography screening according to breast density
Interventions
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Tailored screening according to breast density
Different interval of mammography screening according to breast density
Annual invitation to mammography
Annual interval mammography screening according to international guidelines for women younger than 50 years old
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* women with family high risk for breast cancer
* previous diagnosis of other cancers in the last 5 years
* early menopause women or in hormone replacement therapy
44 Years
50 Years
FEMALE
Yes
Sponsors
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Ministry of Health, Italy
OTHER_GOV
Cancer Prevention and Research Institute, Italy
OTHER
Responsible Party
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Principal Investigators
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Paola Mantellini, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Prevention and Research Institute, ISPO
Locations
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Cancer Prevention and Research Institute, ISPO
Florence, FI, Italy
Local Health Unit
Forlì, Forlì-Cesena, Italy
CPO Piemonte
Torino, Torino, Italy
Local Health Unit n. 13
Mirano, Venezia, Italy
Local Health Unit n. 4
Thiene, Vicenza, Italy
Countries
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Central Contacts
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References
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Kerlikowske K, Zhu W, Hubbard RA, Geller B, Dittus K, Braithwaite D, Wernli KJ, Miglioretti DL, O'Meara ES; Breast Cancer Surveillance Consortium. Outcomes of screening mammography by frequency, breast density, and postmenopausal hormone therapy. JAMA Intern Med. 2013 May 13;173(9):807-16. doi: 10.1001/jamainternmed.2013.307.
Paci E, Giorgi Rossi P. Tailored screening for breast cancer in premenopausal women: not just looking at sensitivity, but aiming to reduce burden. Womens Health (Lond). 2010 Jul;6(4):477-9. doi: 10.2217/whe.10.32. No abstract available.
Assi V, Warwick J, Cuzick J, Duffy SW. Clinical and epidemiological issues in mammographic density. Nat Rev Clin Oncol. 2011 Dec 6;9(1):33-40. doi: 10.1038/nrclinonc.2011.173.
Vachon CM, van Gils CH, Sellers TA, Ghosh K, Pruthi S, Brandt KR, Pankratz VS. Mammographic density, breast cancer risk and risk prediction. Breast Cancer Res. 2007;9(6):217. doi: 10.1186/bcr1829.
Pataky R, Ismail Z, Coldman AJ, Elwood M, Gelmon K, Hedden L, Hislop G, Kan L, McCoy B, Olivotto IA, Peacock S. Cost-effectiveness of annual versus biennial screening mammography for women with high mammographic breast density. J Med Screen. 2014 Dec;21(4):180-8. doi: 10.1177/0969141314549758. Epub 2014 Sep 3.
Blanch J, Sala M, Ibanez J, Domingo L, Fernandez B, Otegi A, Barata T, Zubizarreta R, Ferrer J, Castells X, Rue M, Salas D; INCA Study Group. Impact of risk factors on different interval cancer subtypes in a population-based breast cancer screening programme. PLoS One. 2014 Oct 21;9(10):e110207. doi: 10.1371/journal.pone.0110207. eCollection 2014.
Boyd NF, Huszti E, Melnichouk O, Martin LJ, Hislop G, Chiarelli A, Yaffe MJ, Minkin S. Mammographic features associated with interval breast cancers in screening programs. Breast Cancer Res. 2014 Aug 26;16(4):417. doi: 10.1186/s13058-014-0417-7.
Holm J, Humphreys K, Li J, Ploner A, Cheddad A, Eriksson M, Tornberg S, Hall P, Czene K. Risk factors and tumor characteristics of interval cancers by mammographic density. J Clin Oncol. 2015 Mar 20;33(9):1030-7. doi: 10.1200/JCO.2014.58.9986. Epub 2015 Feb 2.
Evans DG, Howell A. Can the breast screening appointment be used to provide risk assessment and prevention advice? Breast Cancer Res. 2015 Jul 9;17(1):84. doi: 10.1186/s13058-015-0595-y.
Other Identifiers
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RF-2009-1493239
Identifier Type: -
Identifier Source: org_study_id
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