Title: Study of everolimus with hormone therapy in women with high-risk breast cancer (ER-positive, HER2-negative) who are disease-free after initial treatment

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What is this study about?

This study focuses on women with breast cancer that is hormone receptor-positive (ER+) and HER2-negative, who have completed their initial treatment but have a high risk of the cancer returning. The study examines whether adding a medication called everolimus (Afinitor) to standard hormone therapy can help prevent the cancer from coming back.

The medication being tested, everolimus, is taken as tablets by mouth along with regular hormone therapy. Some participants will receive everolimus tablets while others will receive placebo tablets. The treatment continues for 2 years, during which time participants take their assigned medication in addition to their standard hormone therapy.

The main goal of this research is to determine if adding everolimus to standard hormone treatment helps keep patients cancer-free for a longer time. Throughout the study, doctors will monitor participants’ health and track whether the cancer returns. The study will also look at how well patients tolerate the treatment combination and its effects on their overall health.

1 Initial evaluation

Your eligibility for the study will be confirmed through medical examination and review of your breast cancer history

Laboratory tests will check your blood count, liver function, and kidney function to ensure they meet required levels

Your tumor status will be verified as hormone receptor positive and HER2 negative

2 Treatment assignment

You will be randomly assigned to receive either Afinitor 5 mg tablets (everolimus) or placebo tablets

Both medications are taken by mouth

This assignment is double-blind, meaning neither you nor your doctor will know which treatment you receive

3 Treatment period

The treatment duration is 2 years

You will continue your current hormone therapy (tamoxifen, letrozole, anastrozole, or exemestane)

You will take the study medication (Afinitor or placebo) in addition to your hormone therapy

4 Monitoring

Regular check-ups will monitor your health status

Your doctor will assess any side effects using standard medical criteria

Quality of life assessments will be conducted using a questionnaire

Tests will be performed to check for any signs of cancer return

5 Study completion

The study continues until March 2025

Your participation will help determine if adding everolimus to hormone therapy improves outcomes for breast cancer patients

The main measure of success is the time without return of cancer (disease-free survival)

Who Can Join the Study?

  • Must be a female aged 18 years or older
  • Must have adequate blood cell counts:
    – Normal levels of neutrophils (white blood cells that fight infection)
    – Normal levels of platelets (blood cells that help with clotting)
  • Must have normal liver function, shown by standard blood tests (AST, ALT, alkaline phosphatase, and bilirubin)
  • Must have normal kidney function, measured by blood creatinine levels
  • Must provide written informed consent to participate
  • Must have confirmed breast cancer that has been proven through tissue examination
  • Must have breast cancer that has not spread to other parts of the body
  • Must be at high risk for cancer returning
  • Must have breast cancer that is:
    Hormone receptor positive (responds to hormones)
    HER2 negative (does not have high levels of HER2 protein)
  • Must have had the primary tumor completely removed by surgery
  • Must either:
    – Be ready to start hormone therapy, or
    – Have been on hormone therapy for no more than 4 years
  • Must have no signs of cancer spread at the time of joining the study
  • Must be able to perform daily activities with little or no assistance (good performance status)

Who Cannot Join the Study?

  • Previous or current diagnosis of metastatic breast cancer (cancer that has spread to other parts of the body)
  • Male patients (study is only open to female participants)
  • Patients with HER2-positive or hormone receptor-negative breast cancer
  • Patients who are not currently disease-free after initial treatment
  • Patients who are not receiving standard hormone therapy
  • Patients with signs of cancer recurrence
  • Current participation in other clinical trials
  • History of serious allergic reactions to similar medications
  • Severe kidney or liver problems
  • Uncontrolled medical conditions that could interfere with the study
  • Inability to follow study procedures or attend scheduled visits
  • Pregnancy or breastfeeding
  • History of other cancers within the past 5 years (except treated non-melanoma skin cancer)

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
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Clinique Pasteur Toulouse France
Centre Hospitalier Intercommunal Creteil Creteil France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Centre Hospitalier Blois Simone Veil Blois France
Grand Hopital De Charleroi Charleroi Belgium
CHR Verviers Verviers Belgium
Les Hopitaux De Chartres Le Coudray France
Institut Godinot Reims France
Centre Hospitalier Public Du Cotentin Cherbourg-En-Cotentin France
Centre Hospitalier Jean Rougier Cahors France
Clinique De La Sauvegarde Lyon France
Hopital Ambroise Pare Boulogne-Billancourt France
Capio La Croix Du Sud Quint-Fonsegrives France
CHC MontLegia Liege Belgium
Groupe Hospitalier Bretagne Sud Lorient France
Hopital Prive Des Cotes D’armor Plerin France
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
CHU Helora La Louviere Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Hopital De Libramont Libramont-Chevigny Belgium
Institut Sainte Catherine Avignon France
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Oncoradio Centre Oncogard Nimes France
Cbozdq Lskd Bkakji Lyon France
Hsldbfbi dq Llrxv Thonon-les-bains France
Hggigsy Ahqqmabih Neuilly-Sur-Seine France
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Gshtxbiirz Hblnxkznpdg Phfpas Ds Pwopuivp Montélimar France
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Cpmazunwa Uwwqtlrfbxbdmt Szwsypneq Woluwe-Saint-Lambert Belgium
Hkthxdu Pkrxs Dgjfyninkavkk Valence France
Cqkdcx Hyhjtfitjmh Eh Uolvmxhltmufa Dz Lftmkfb Limoges France
Acovgcssyq Pwenqeku Hvudmyss Dj Pjnwc Paris France
Ijbjrttc dc Cyhubhdbgyrg Herrrvvweoj Ubzbzskesbtvy dr Sbfoe Ezhqfrn (wefuqur Saint Priest En Jarez France
Csatdw Oxvyd Ledeusa Lille France
Hyakapiz Udpovfoqpjlsfs Susrxiksxq &rtqqsb Hlnqtod dg Hijjoektrcf STRASBOURG, Alsace France
Cvozwtohw dv Skptdqzvtxzowe Arlon Belgium
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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
Belgium Belgium
Not recruiting
05.06.2013
France France
Not recruiting
05.06.2013

Trial locations

Investigated drugs:

Everolimus is a medication that works by helping to stop cancer cells from growing. It belongs to a group of drugs called mTOR inhibitors. In breast cancer treatment, it works alongside hormone therapy to help prevent the cancer from returning in patients who have hormone receptor-positive breast cancer.

Hormone therapy (also called endocrine therapy) is a treatment that blocks or lowers the amount of hormones in the body to stop or slow down the growth of hormone-dependent breast cancer. This therapy is commonly used after surgery in women with hormone receptor-positive breast cancer to reduce the risk of cancer coming back.

Breast Cancer (ER-positive, HER2-negative) – A type of breast cancer characterized by the presence of estrogen receptors (ER+) but lacking human epidermal growth factor receptor 2 (HER2-). This cancer begins when abnormal cells in the breast tissue start growing uncontrollably. The cancer cells in this type respond to the hormone estrogen, which can stimulate their growth. These cancer cells typically develop in the milk ducts or milk-producing glands of the breast. The disease can remain localized within the breast or spread to nearby lymph nodes. This particular subtype is one of the most common forms of breast cancer.

Trial ID:
2024-516198-61-00
Protocol code:
UC-0140/1208
NCT ID:
NCT01805271
Trial Phase:
Therapeutic confirmatory (Phase III)

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