Breast CancerTBSTNCT02619123
Tailored Screening for Breast Cancer in Premenopausal Women
A study testing Tailored screening according to breast density and Annual invitation to mammography in people with Breast Cancer, run by Cancer Prevention and Research Institute, Italy at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 44 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tailored screening according to breast density and Annual invitation to mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,200 participants
- Where
- 5 sitesItaly
- Study dates
- Jan 2013to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women 44-45 years old resident in the screening area
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Cancer Prevention and Research Institute, ISPO
Florence, FI, 50139
Paola Mantellini, MD
- Not yet recruiting
Local Health Unit
Forlì, Forlì-Cesena, 47121
Fabio Falcini, MD
- Recruiting
Local Health Unit n. 13
Mirano, Venezia, 30035
Adriana Montaguti, MD
- Recruiting
Local Health Unit n. 4
Thiene, Vicenza, 36016
Flavio Banovich, MD
- Recruiting
CPO Piemonte
Torino, Torino, 10121
Livia Giordano, MD
About this study
Official title: Tailored Screening for Breast Cancer in Premenopausal Women. A Translational, Randomized Population-based Trial
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.
Read the detailed description
Introduction: the Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised trial aimed at evaluating the impact of a change in the screening protocol in a service screening practice. "Tailored" means that the use of a breast density classification allocates women to a longer interval, decreasing the number of screening rounds in the 45-50-year age range. Density of the breast at the baseline is considered as an indicator of risk and also as a masking factor. The aim of this study is to assess the impact of a longer interval and the reduction of side effects for women allocated to the intervention group. In this study, any further intervention is offered to high-density women who are followed-up according to the usual care interval, since the study aimed at decreasing the screening burden.
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
- Breast Cancer
- Being tested
- Tailored screening according to breast density, Annual invitation to mammography
- Keywords
- breast density, breast cancer, risk-based screening, Tailored breast cancer screening, premenopausal women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored screening according to breast densityOther
Different interval of mammography screening according to breast density
Annual invitation to mammographyOther
Annual interval mammography screening according to international guidelines for women younger than 50 years old
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Tailored screening according to breast density |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: three and six years
Secondary outcomes (3)
Comparison of false positive rates by arm and by density group
The "false positive rate" is measured as the sum of women with a positive mammography in a screening round without a breast cancer divided by the sum of screened women in the same round.
Measured: 3 and 6 years
Comparison of cumulative incidence of breast cancer cases by arm and by density group.
The "cumulative incidence of breast cancer" is the cumulative number of breast cancers divided by the number of enrolled women.Breast cancer cases will be retrieved by linking the of enrolled women with cancer registry information
Measured: 3 and 6 years
Comparison of attendance to mammography screening by arm and by density group.
The "attendance to mammography screening" is measured as the number of women attending screening mammography on the number of invited women.
Measured: 1, 2, 3, 4, 5 and 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Prevention and Research Institute, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Paola Mantellini, MD, Principal investigator, Cancer Prevention and Research Institute, ISPO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619123
- Sponsor's protocol ID
- RF-2009-1493239
- Acronym
- TBST
- Status last verified
- Feb 2017
- First submitted
- 12 Nov 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23552817Paci 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.
PubMed 20597608Assi 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.
PubMed 22143145Vachon 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.
PubMed 18190724Pataky 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.
PubMed 25186116Blanch 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.
PubMed 25333936Boyd 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.
PubMed 25346388Holm 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.
PubMed 25646195Evans 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.
PubMed 26155950
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Screening for Breast Cancer in Premenopausal Women. A Translational, Randomized Population-based Trial
- ClinicalTrials.gov ID
- NCT02619123
- Acronym / sponsor ID
- TBST / RF-2009-1493239
- Conditions
- Breast Cancer
- Keywords
- breast density, breast cancer, risk-based screening, Tailored breast cancer screening, premenopausal women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33,200 participants (estimated)
- Lead sponsor
- Cancer Prevention and Research Institute, ItalyUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- Jan 2013
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: the Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised trial aimed at evaluating the impact of a change in the screening protocol in a service screening practice. "Tailored" means that the use of a breast density classification allocates women to a longer interval, decreasing the number of screening rounds in the 45-50-year age range. Density of the breast at the baseline is considered as an indicator of risk and also as a masking factor. The aim of this study is to assess the impact of a longer interval and the reduction of side effects for women allocated to the intervention group. In this study, any further intervention is offered to high-density women who are followed-up according to the usual care interval, since the study aimed at decreasing the screening burden.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| invitation to mammography screening | Active comparator | Other: Annual invitation to mammography44-45 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. |
| invitation to tailored screening | Experimental | Other: Tailored screening according to breast density44-45 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. |
Who may qualify
- Ages
- 44 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women 44-45 years old resident in the screening area
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored screening according to breast densityDifferent interval of mammography screening according to breast density | Other | invitation to tailored screening |
| Annual invitation to mammographyAnnual interval mammography screening according to international guidelines for women younger than 50 years old | Other | invitation to mammography screening |
Primary outcome
Comparison of cumulative incidence of interval cancer cases by arm and by density group
Time frame: three and six years
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
Comparison of cumulative incidence of T2+/node-positive status breast cancer cases by arm and by density group.
Time frame: three and six years
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
3 secondary outcomes
Comparison of false positive rates by arm and by density group
Time frame: 3 and 6 years
Comparison of cumulative incidence of breast cancer cases by arm and by density group.
Time frame: 3 and 6 years
Comparison of attendance to mammography screening by arm and by density group.
Time frame: 1, 2, 3, 4, 5 and 6 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 23552817Kerlikowske 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.
- Background: PubMed 20597608Paci 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.
- Background: PubMed 22143145Assi 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.
- Background: PubMed 18190724Vachon 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.
- Background: PubMed 25186116Pataky 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.
- Background: PubMed 25333936Blanch 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.
- Background: PubMed 25346388Boyd 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.
- Background: PubMed 25646195Holm 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.
- Background: PubMed 26155950Evans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Mantellini, MD principal investigator
Cancer Prevention and Research Institute, ISPO
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored screening according to breast density and Annual invitation to mammography in people with Breast Cancer, run by Cancer Prevention and Research Institute, Italy at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Mantellini, MDr (00390557972509, p.mantellini@ispo.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cumulative incidence of interval cancer cases by arm and by density group (time frame: three and six years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619123, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.