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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Ospedale Santa Maria Annunziata	Bagno A Ripoli	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
San Raffaele Scientific Institute	Milan	Italy
Azienda USL Toscana Centro	Prato	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Iodmdu Ibfdatwp Fmatbocdfqptr Ogawyxyijxd	Rome	Italy
Agoejnv Odshgamdeca Nogpeasas Sb Acxoykw E Blhkml E C Arykpm Awysitzvuqy	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	08.02.2021

Trial locations

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.

Investigated diseases:

Breast cancer

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.

Trial ID:

2023-508094-88-00

Protocol code:

EUROPA

NCT ID:

NCT04134598

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?