Tailored Screening for Breast Cancer in Premenopausal Women (TBST)

February 9, 2017 updated by: Cancer Prevention and Research Institute, Italy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

33200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Torino, Italy, 10121
        • Recruiting
        • CPO Piemonte
        • Principal Investigator:
          • Livia Giordano, MD
    • FI
      • Firenze, FI, Italy, 50139
        • Recruiting
        • Cancer Prevention and Research Institute, ISPO
        • Principal Investigator:
          • Paola Mantellini, MD
    • Forlì-Cesena
      • Forlì, Forlì-Cesena, Italy, 47121
        • Not yet recruiting
        • Local Health Unit
        • Principal Investigator:
          • Fabio Falcini, MD
    • Venezia
      • Mirano, Venezia, Italy, 30035
        • Recruiting
        • Local Health Unit n. 13
        • Principal Investigator:
          • Adriana Montaguti, MD
    • Vicenza
      • Thiene, Vicenza, Italy, 36016
        • Recruiting
        • Local Health Unit n. 4
        • Principal Investigator:
          • Flavio Banovich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

44 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Annual invitation to mammography
Annual interval mammography screening according to international guidelines for women younger than 50 years old
Experimental: 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.
Other: Tailored screening according to breast density
Different interval of mammography screening according to breast density

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three and six years
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
three and six years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of false positive rates by arm and by density group
Time Frame: 3 and 6 years
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.
3 and 6 years
Comparison of cumulative incidence of breast cancer cases by arm and by density group.
Time Frame: 3 and 6 years
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
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
The "attendance to mammography screening" is measured as the number of women attending screening mammography on the number of invited women.
1, 2, 3, 4, 5 and 6 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Prevention and Research Institute, Italy

Collaborators

Ministry of Health, Italy

Investigators

  • Principal Investigator: Paola Mantellini, MD, Cancer Prevention and Research Institute, ISPO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2009-1493239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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