Tailored Screening for Breast Cancer in Premenopausal Women

NCT02619123 | Unknown

• 1 other identifier: RF-2009-1493239
• Study Type: interventional
• Target: 33,200
• Locations: 1 country
• Sites: 5

Brief Summary

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

Breast Cancer

Keywords

breast density; breast cancer; risk-based screening; Tailored breast cancer screening; premenopausal women

Outcome Measures

Primary Outcomes (2)

• Comparison of cumulative incidence of interval cancer cases by arm and by density group

  An "interval cancer" is, according to European guidelines for quality assurance, a primary breast cancer which is diagnosed in a woman who had a screening test negative for malignancy within a time period equal to the screening interval. Interval cancers will be retrieved by linking the cancer registry and screening archive. The "cumulative incidence of interval cancers" is the number of interval cancers divided by the number of screened women

  three and six years

• Comparison of cumulative incidence of T2+/node-positive status breast cancer cases by arm and by density group.

  The "cumulative incidence of T2+/N+ breast cancer" is the number of cancers T2+/N+, regardless the modality of detection (screen-detected, interval cancer, etc.), divided by the number of screened women

  three and six years

Secondary Outcomes (3)

• Comparison of false positive rates by arm and by density group

  3 and 6 years

• Comparison of cumulative incidence of breast cancer cases by arm and by density group.

  3 and 6 years

• Comparison of attendance to mammography screening by arm and by density group.

  1, 2, 3, 4, 5 and 6 year

Study Arms (2)

invitation to mammography screening

ACTIVE COMPARATOR

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.

Other: Annual invitation to mammography

invitation to tailored screening

EXPERIMENTAL

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.

Other: Tailored screening according to breast density

Interventions

Tailored screening according to breast density OTHER

Different interval of mammography screening according to breast density

invitation to tailored screening

Annual invitation to mammography OTHER

Annual interval mammography screening according to international guidelines for women younger than 50 years old

invitation to mammography screening

Eligibility Criteria

• Age: 44 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women 44-45 years old resident in the screening area

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Prevention and Research Institute, Italy: lead
• Ministry of Health, Italy: collaborator

Study Sites (5)

Cancer Prevention and Research Institute, ISPO

Florence, FI, 50139, Italy

RECRUITING

Local Health Unit

Forlì, Forlì-Cesena, 47121, Italy

NOT YET RECRUITING

CPO Piemonte

Torino, Torino, 10121, Italy

RECRUITING

Local Health Unit n. 13

Mirano, Venezia, 30035, Italy

RECRUITING

Local Health Unit n. 4

Thiene, Vicenza, 36016, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 23552817 BACKGROUND

• 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.

  PMID: 20597608 BACKGROUND

• 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.

  PMID: 22143145 BACKGROUND

• 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.

  PMID: 18190724 BACKGROUND

• 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.

  PMID: 25186116 BACKGROUND

• 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.

  PMID: 25333936 BACKGROUND

• 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.

  PMID: 25346388 BACKGROUND

• 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.

  PMID: 25646195 BACKGROUND

• 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.

  PMID: 26155950 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paola Mantellini, MD

  Cancer Prevention and Research Institute, ISPO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Mantellini, MDr

CONTACT

00390557972509; p.mantellini@ispo.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: December 2, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

IT (5)