Study on Reducing Hormone Therapy Duration with Exemestane, Letrozole, and Anastrozole in Post-Menopausal Women with Low-Risk Hormone-Sensitive Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as hormone receptor-positive (HR+) HER2-negative breast cancer in post-menopausal women. The study is specifically looking at women who have a very low risk of the cancer spreading to other parts of the body, known as metastasis. The treatment being studied involves the use of medications called aromatase inhibitors, which include exemestane, letrozole, and anastrozole. These medications are taken orally in the form of tablets.

The purpose of the study is to see if a shorter duration of hormone therapy, specifically two years, is effective in maintaining a high rate of survival without the cancer spreading over a period of five years. Participants in the study will take one of the aromatase inhibitors for up to two years. The study will monitor the participants’ health and any side effects they may experience during this time. The goal is to determine if reducing the length of hormone therapy can still provide effective treatment for this type of breast cancer.

Throughout the study, researchers will track several outcomes, including how long participants remain free from distant metastasis, which means the cancer has not spread to other parts of the body. They will also look at overall survival rates, quality of life, and any adverse effects from the treatment. The results from this study will be compared to those from another study where patients received hormone therapy for five years. This comparison will help determine the safety and effectiveness of the shorter treatment duration.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria. This includes being a postmenopausal woman with localized luminal A breast cancer at low risk of metastatic relapse.

Eligibility also requires that the primary tumor has been completely removed and adequate axillary surgery has been performed.

2 treatment initiation

The treatment involves taking an adjuvant hormone therapy. The options include letrozole, anastrozole, or exemestane. These medications are taken orally.

The therapy is administered for a duration of 2 years. The specific dosage and frequency are determined by the healthcare provider.

3 treatment duration

The main objective is to demonstrate that a 2-year duration of this therapy is effective in maintaining high survival rates without distant metastasis over 5 years.

Regular follow-ups and assessments are conducted to monitor health status and any potential side effects.

4 monitoring and follow-up

Throughout the study, various health parameters are monitored, including distant metastasis-free survival, invasive disease-free survival, and overall survival.

Quality of life assessments are also conducted to evaluate the impact of the treatment.

5 completion

The study is estimated to conclude by March 31, 2034. Upon completion, the data collected will be analyzed to assess the effectiveness and safety of the reduced hormone therapy duration.

Who Can Join the Study?

  • Must be a postmenopausal woman. This means you have stopped having periods due to age or surgery.
  • Eligible to start or have recently started (within the last 4 months) adjuvant hormone therapy with medications like letrozole, anastrozole, or exemestane. These are treatments given after the main treatment to lower the chance of cancer returning.
  • Willing and able to follow the study plan, including attending scheduled visits and undergoing tests and procedures.
  • Must be part of a Social Security System or something similar.
  • Must have signed a written consent form to participate. If unable to sign, a trusted person can sign on your behalf.
  • Have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can carry out light work.
  • Have invasive unilateral breast cancer, meaning cancer is in one breast and has spread into surrounding breast tissue.
  • No signs of metastases, which means the cancer has not spread to other parts of the body.
  • The primary tumor must be completely removed, and proper surgery on the lymph nodes under the arm must have been done.
  • Cancer cells must show at least 50% expression of estrogen or progesterone receptors, which are proteins that can attach to hormones and affect cancer growth.
  • Cancer must be HER2 negative, meaning it does not have high levels of a protein that can promote cancer growth.
  • Considered to have a luminal A ultralow risk of cancer returning, meaning less than a 5% chance of cancer coming back in 10 years, based on specific tests called MammaPrint® and Blueprint®.

Who Cannot Join the Study?

  • Patients who are not post-menopausal. This means women who have not yet gone through menopause, which is when menstrual periods permanently stop.
  • Patients who do not have localized luminal A breast cancer. This is a specific type of breast cancer that is usually slower growing and has certain hormone receptors.
  • Patients who are considered at high risk of metastatic relapse. This means the cancer is likely to spread to other parts of the body.
  • Patients who are not female, as the study is only for women.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Reseau De Sante Mutualiste Villeurbanne France
Centre Jean Perrin Clermont Ferrand France
Centr Georges Francois Leclerc Dijon France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Blois Simone Veil Blois France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Clinique Pasteur Lanroze Brest France
Clinique Medico Chirurgicale Charcot Sainte-Foy-Les-Lyon France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
Polyclinique De Limoges Limoges France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Hopital NOVO Pontoise France
Centre Hospitalier De Cholet Cholet France
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Centre Hospitalier D Auxerre Auxerre France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
IHFB Cognacq Jay Levallois-Perret France
Institut Sainte Catherine Avignon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Centre Hospitalier De Pau Pau France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Groupe Hospitalier Rance Emeraude Saint-Malo France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Clinique Mutualiste de l’Estuaire St Nazaire France
Clinique des Cèdres Cornebarrieu France
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Clvajt Hnzgtzbxlwd db Gxqblx Grasse France
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Ijstrynl Pkefbxmcgpxmjwm Crilpu Csjmml Marseille France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.11.2022

Trial locations

Aromatase Inhibitor is a type of medication used in this trial to help reduce the risk of breast cancer returning. It works by lowering the amount of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this study, the focus is on using this medication for a shorter period to see if it is still effective in preventing cancer from coming back in women who are at a very low risk of metastasis.

Localized Luminal A Breast Cancer – This is a type of breast cancer that is typically found in post-menopausal women. It is characterized by cancer cells that are hormone receptor-positive and HER2-negative, which means they grow in response to hormones like estrogen. Luminal A breast cancer is generally considered to be a slow-growing cancer with a lower risk of spreading to other parts of the body. It is often detected at an early stage when it is still confined to the breast tissue. The progression of this cancer is usually gradual, and it is often associated with a favorable prognosis compared to other types of breast cancer.

Trial ID:
2024-514480-26-00
Protocol code:
UC-BCG-2103
NCT ID:
NCT05297617
Trial Phase:
Therapeutic exploratory (Phase II)

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