Not recruiting

Study on Anastrozole, Letrozole, Exemestane, and Tamoxifen for Women Aged 70+ with Early Stage Breast Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for breast cancer, specifically in women aged 70 years and older with a type of early-stage breast cancer known as luminal A-like. The study is comparing two treatment approaches: exclusive hormone therapy and radiation therapy. Hormone therapy involves medications that help block or lower the amount of hormones in the body to slow down or stop the growth of cancer. The medications being studied include anastrozole, letrozole, exemestane, and tamoxifen. These medications are taken orally, meaning they are swallowed in pill form.

The purpose of the study is to determine the effectiveness of these treatments in preventing the return of cancer after surgery, as well as to assess the quality of life of the participants. Participants will be randomly assigned to receive either hormone therapy or radiation therapy after undergoing breast-conserving surgery, which is a type of surgery that removes the cancer while keeping as much of the breast as possible. The study will last for a period of up to five years, during which participants will be monitored regularly to track their health and any side effects they may experience.

Throughout the study, participants will be asked to complete questionnaires about their quality of life, which will help researchers understand how the treatments affect their daily lives. The study aims to provide valuable information on the best treatment options for older women with this specific type of breast cancer, helping to improve care and outcomes for future patients. Participants will receive either the hormone therapy or radiation therapy, or a placebo, as part of the study's design to compare the different treatment effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of breast cancer, and previous surgical treatment.
Written informed consent is required to participate in the trial.
Step 2
Randomization
Participants are randomly assigned to one of two groups: exclusive endocrine therapy or exclusive radiation therapy.
This process ensures that each participant has an equal chance of receiving either treatment.
Step 3
Endocrine therapy
If assigned to the endocrine therapy group, medications such as anastrozole, letrozole, or exemestane are administered orally.
The specific medication and dosage depend on individual medical assessments and are taken as prescribed by the healthcare provider.
Step 4
Radiation therapy
If assigned to the radiation therapy group, treatment involves targeted radiation sessions.
The frequency and duration of these sessions are determined by the healthcare team based on individual needs.
Step 5
Follow-up assessments
Regular follow-up assessments are conducted to monitor health and treatment effects.
These assessments include questionnaires to evaluate quality of life and other health-related outcomes at various intervals: baseline, 3, 6, 12, 24 months, and 5 years.
Step 6
End of trial
The trial is expected to conclude by February 28, 2029.
Final assessments are conducted to evaluate the long-term effects of the treatments.

Who can join the trial?

9 criteria

Women aged 70 years or older
Confirmed diagnosis of invasive adenocarcinoma of the breast, which is a type of breast cancer
Cancer is at stage T1, meaning the tumor is small
After surgery, the edges of the removed tissue are free of cancer cells
No cancer in the lymph nodes, which are small glands that help fight infection (a few isolated tumor cells are allowed)
Any tumor grade if the tumor is 10 mm or smaller; for tumors between 11 and 19 mm, the grade should be G1 or G2, which indicates how much the cancer cells look like normal cells
Cancer has luminal A-like biology, which means: estrogen receptor (ER) and progesterone receptor (PgR) are positive (10% or more), human epidermal growth factor receptor 2 (HER2) is negative, and Ki67, a marker of cell growth, is low (20% or less)
Underwent breast-conserving surgery (BCS), which removes the cancer but not the whole breast, with or without a sentinel node biopsy (SNB), a procedure to check if cancer has spread to the lymph nodes
Provided written informed consent, which means agreeing to participate after understanding the study

Who cannot join the trial?

3 criteria

Patients who are not female cannot participate in the study.
Patients who are younger than 70 years old cannot participate in the study.
Patients who do not have low-risk early breast cancer cannot participate in the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Verified
Alexandria, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Endocrine Therapy (ET)
is a treatment used to block or lower the amount of hormones in the body to slow down or stop the growth of hormone-sensitive tumors. In this trial, it is used exclusively to treat women aged 70 years or older with low-risk early-stage breast cancer.
Radiation Therapy (RT)
is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used exclusively to treat women aged 70 years or older with low-risk early-stage breast cancer.

What is already known about the treatment

Endocrine Therapy
This medication is administered orally or through injection, depending on the specific drug used within the therapy. It is currently well-established in medical practice and literature for treating hormone receptor-positive breast cancer. The main therapeutic indication is to reduce the risk of cancer recurrence by blocking or lowering the amount of hormones in the body. At the molecular level, it works by interfering with the hormone receptors or the production of hormones that fuel cancer growth. It is classified under hormonal therapy in pharmacology.
Radiation Therapy
This treatment is applied externally using high-energy rays directed at the cancer site. It is a standard and widely recognized treatment in medical literature for various types of cancer, including breast cancer. The primary therapeutic indication is to destroy cancer cells and reduce the risk of recurrence after surgery. The mechanism of action involves damaging the DNA of cancer cells, which prevents them from growing and dividing. It is classified as a form of localized cancer treatment.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. Early stages may not cause noticeable symptoms, but as it advances, symptoms like changes in breast shape, skin dimpling, or nipple discharge may occur. The disease is categorized into stages based on the size of the tumor and the extent of spread to lymph nodes or other organs. Regular screening and monitoring are crucial for managing its progression.