Study on Breast Cancer Prevention in High-Risk Women Using Low Dose Tamoxifen and Lifestyle Changes

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What is this study about?

This clinical trial is focused on preventing breast cancer in women who are at an increased risk. The study involves the use of a medication called Low Dose Tamoxifen, which is a type of drug that can help in reducing the risk of developing breast cancer. Participants in the study may also be asked to make changes to their diet and lifestyle, which could include adjustments to their eating habits and physical activity levels.

The purpose of the study is to determine if Low Dose Tamoxifen can increase the levels of a protein in the blood called Sex Hormone Binding Globulin (SHBG) more effectively than lifestyle changes alone. The study will involve women who are healthy but have a higher risk of breast cancer due to genetic factors or previous medical conditions. These women may carry certain genetic mutations, such as BRCA1 or BRCA2, or have a history of conditions like intraepithelial neoplasia, which is a type of abnormal cell growth in the breast.

Participants will be randomly assigned to one of four groups, where they will receive either Low Dose Tamoxifen, lifestyle changes, or a combination of both. The study will last for several months, during which time participants will have regular check-ups to monitor their health and the levels of various substances in their blood. The main focus will be on the levels of SHBG, but other factors such as insulin, glucose, and body composition will also be observed. The study aims to provide valuable insights into how these interventions can help in the prevention of breast cancer.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study and what to expect. You will be asked to sign a consent form to confirm your understanding and willingness to participate.

A series of baseline assessments will be conducted, including a review of your medical history and a physical examination. These assessments help determine your eligibility and establish a starting point for the study.

2 randomization

After the initial assessments, you will be randomly assigned to one of four groups. This process is called randomization and ensures that each participant has an equal chance of being placed in any group.

The groups may involve different interventions, such as taking a low dose of tamoxifen citrate or making lifestyle changes. The specific group you are assigned to will determine the course of your participation.

3 intervention period

If you are assigned to the group taking tamoxifen citrate, you will take a 10 mg film-coated tablet orally each day. This medication is known as Nolvadex.

The intervention period lasts for six months. During this time, you will follow the instructions specific to your group, whether it involves medication, lifestyle changes, or both.

4 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the intervention.

During these visits, various tests and assessments will be conducted, such as blood tests to measure hormone levels and other biomarkers. Your overall health and any side effects will also be evaluated.

5 final assessment

At the end of the six-month intervention period, a final assessment will be conducted. This assessment will include a comprehensive evaluation of your health and the outcomes of the intervention.

The results of this assessment will help determine the effectiveness of the intervention in increasing levels of circulating sex hormone binding globulin and other health markers.

Who Can Join the Study?

Women aged between 18 and 70 years old.
Must be healthy and either:
- Carriers of a germline pathogenic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C, or RAD51D. A germline pathogenic variant is a change in a gene that can increase the risk of developing certain diseases.
- Have a breast cancer risk greater than 5% over the next 10 years, as determined by specific risk models.
- Have been previously diagnosed with intraepithelial neoplasia (IEN), which is a condition where abnormal cells are found in the breast, and have had surgery for conditions like ADH, LCIS, or ER positive DCIS within the last 3 years.
Must be able to understand and willing to sign a written informed consent document.
Have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day. Alternatively, a Karnofsky score of 70% or higher, which measures the ability to carry out daily activities.
For those at high risk:
- A negative mammogram or any other required radiological image based on age and center protocol screening within 6 months before the start of the study.
For those with IEN:
- A bilateral mammogram within 12 months before the start of the study is required. The mammogram done before breast surgery is acceptable.
A negative transvaginal ultrasound or hysteroscopy within 6 months before the start of the study. A transvaginal ultrasound is an imaging test to look at the female reproductive organs. Women who have had a hysterectomy (removal of the uterus) for a non-cancerous condition do not need this test.

Who Cannot Join the Study?

Women who are not between the ages of 18 and 70.
Women who are not healthy carriers of a germline pathogenic variant (specific genetic changes that can be passed from parents to children) such as BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C, or RAD51D.
Women who do not have a breast cancer risk greater than 5% over the next 10 years, as determined by specific risk models.
Women who have not been previously treated for breast IEN (intraepithelial neoplasia), which refers to abnormal cells in the breast tissue.
Men are not eligible to participate in this study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ente Ospedaliero Ospedali Galliera Di Genova	Genoa	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Aawskbt Usyna Lzvzbq Sokef Sjsgpmamx No 1 Dpccpusa	Belluno	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Tamoxifen Citrate

Low Dose Tamoxifen is a medication used in this study to help prevent breast cancer in people who are at a higher risk. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, the researchers are looking to see if taking a lower dose of Tamoxifen can increase the levels of a protein called Sex Hormone Binding Globulin (SHBG) in the blood, which might help in reducing the risk of developing breast cancer.

Lifestyle Intervention is a non-medication approach used in the study to help prevent breast cancer. It involves making changes to daily habits, such as improving diet, increasing physical activity, and possibly incorporating intermittent caloric restriction, which means occasionally reducing calorie intake. The goal of these lifestyle changes is to improve overall health and potentially lower the risk of breast cancer by affecting hormone levels and other risk factors.

Investigated diseases:

Breast cancer in situ

Breast Intraepithelial Neoplasia (IEN) – Breast intraepithelial neoplasia refers to abnormal cell growth within the breast ducts or lobules. It is considered a precursor to invasive breast cancer but is not cancer itself. The condition involves changes in the cells lining the breast ducts or lobules, which can increase the risk of developing breast cancer. Over time, these abnormal cells may accumulate genetic mutations that could lead to invasive cancer. The progression from intraepithelial neoplasia to invasive cancer is not guaranteed and varies among individuals. Monitoring and regular check-ups are often recommended to track any changes in the condition.

Trial ID:

2023-503994-39-00

NCT ID:

NCT06033092

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Breast Cancer Prevention in High-Risk Women Using Low Dose Tamoxifen and Lifestyle Changes

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