Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.

questionnaire

Janice Sung, MD

The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.

Blood sample collected at time of MRI for serum hormone analysis Postmenopausal women only

MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.

Determine the relationship between serum hormone levels (testosterone, estradiol (E2), estrone (E1), androstenedione (A4) and sex hormone binding globulin (SHBG)) at the time of MRI and degree of BPE in healthy high-risk postmenopausal women. The association between circulating serum hormone levels and BPE will be determined using linear regression.

National Cancer Institute (NCI)

University of Southern California

University of Toronto

Memorial Sloan Kettering Cancer Center

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

Reproductive Control Agents

Tamoxifen

Hormones

Letrozole

Estrogens

Mitogens

Goserelin

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Anastrozole

Triptorelin Pamoate

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

Tamoxifen 20mg

Anastrozole 1mg

Letrozole 2.5mg

Gonadotropin Releasing Hormone (GnRH) agonist

Triptorelin

Artamonova Elena

Elena Kovalenko

Tatiana Titova

Kovalenko Elena

Titova Tatiana

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Nonrandomized, retrospective clincal trial

Eligible postmenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily before surgery

or

Eligible premenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily in combination with ovarian suppression before surgery

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.

Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.

the preoperative endocrine prognostic index (PEPI)- consisting of the pathological tumor size, pathological node status, Ki67 labeling index, and ER status of residual tumors after NAE

DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

Blokhin's Russian Cancer Research Center

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.

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.

Different interval of mammography screening according to breast density

Tailored screening according to breast density

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

Annual invitation to mammography

Paola Mantellini, MDr

Paola Mantellini, MD

Fabio Falcini, MD

Adriana Montaguti, MD

Flavio Banovich, MD

Livia Giordano, MD

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.

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.

Tailored Screening for Breast Cancer in Premenopausal Women

Tailored Screening for Breast Cancer in Premenopausal Women. A Translational, Randomized Population-based Trial

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

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

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.

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

The "attendance to mammography screening" is measured as the number of women attending screening mammography on the number of invited women.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk	NCT01649661	Cancer Free Wom...	questionnaire	21 Years -	Memorial Sloan Kettering Cancer Center
Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia	NCT05800197	Breast Cancer Neoadjuvant End...	Tamoxifen 20mg Anastrozole 1mg Letrozole 2.5mg Goserelin Triptorelin	18 Years -	Blokhin's Russian Cancer Research Center
Tailored Screening for Breast Cancer in Premenopausal Women	NCT02619123	Breast Cancer	Tailored screen... Annual invitati...	44 Years - 50 Years	Cancer Prevention and Research Institute, Italy

Spots Global Cancer Trial Database for premenopausal women