Clinical trial · Interventional
Tailored Screening for Breast Cancer in Premenopausal Women
Tailored Screening for Breast Cancer in Premenopausal Women. A Translational, Randomized Population-based Trial
NCT02619123CI-TRIAL-00025903TBSTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised trial aimed at evaluating the impact of tailored screening strategies addressed to premenopausal women, by using breast density as indicator of risk. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Annual invitation to mammography | Other | — | UNRESOLVED |
| Tailored screening according to breast density | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- invitation to mammography screening
- description
- 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.
- interventionNames
- Other: Annual invitation to mammography
- type
- EXPERIMENTAL
- label
- invitation to tailored screening
- description
- 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.
- interventionNames
- Other: Tailored screening according to breast density
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 44 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * women 44-45 years old resident in the screening area Exclusion Criteria: * previous diagnosis of invasive or in situ breast cancer * 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
References
Publications (9)
- BACKGROUNDKerlikowske 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. PMID 23552817
- BACKGROUNDPaci 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. PMID 20597608
- BACKGROUNDAssi 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. PMID 22143145
- BACKGROUNDVachon 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. PMID 18190724
- BACKGROUNDPataky 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. PMID 25186116
- BACKGROUNDBlanch 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. PMID 25333936
- BACKGROUNDBoyd 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.