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Gene study aims to personalize breast cancer hormone treatment

NCT ID NCT01127295

Knowledge-focused Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a person's genes and drug levels in the blood affect hormone therapy for breast cancer. It included 2000 women with hormone-sensitive breast cancer who were already scheduled for adjuvant hormone therapy. Researchers measured drug levels and genetic markers over the first 3 years to find links with side effects and early cancer return.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,000 people

The number who actually took part.

Started

Jun 2010

Finished

Dec 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient of more than 18 years old (menopaused or not) 2. Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab 3. Cancer hormone-expressing ER and / or PR (\> 10% tumor cells in Technical HIC) 4. Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary) 5. WHO \<2 6. Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns) 7. signed Consent collected before any specific procedure in the study 8. Patient member in a national insurance scheme. Exclusion Criteria: 1. Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme 2. Metastatic Breast cancer 3. History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months) 4. Any other medical or psychiatric condition or laboratory abnormality severe acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator 5. Patient unable to follow procedures, visits, examinations described in the study 6. Pregnant women or nursing mothers can not participate in the study 7. Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment 8. Patient under legal guardianship

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hormono-depending adjuvant breast cancer

Contacts and locations

Locations

  • CHU de Bordeaux

    Bordeaux, 33000, France

  • CHU de Rangueil

    Toulouse, 31059, France

  • Centre Catalan d'Oncologie

    Perpignan, 66000, France

  • Centre Hospitalier Intercommunal de Castres-Mazamet

    Castres, 81108, France

  • Centre Hospitalier d'Auch

    Auch, 32008, France

  • Centre Hospitalier de Brive

    Brive-la-Gaillarde, 19312, France

  • Centre Hospitalier de Cahors

    Cahors, 46005, France

  • Centre Hospitalier de Mont de Marsan

    Mont-de-Marsan, 40024, France

  • Centre Hospitalier de Montauban

    Montauban, 82013, France

  • Centre Hospitalier de Pau

    Pau, 64000, France

  • Centre Hospitalier de Rodez

    Rodez, 12000, France

  • Centre Val d'Aurelle

    Montpellier, 34298, France

  • Claudius Regaud

    Toulouse, 31052, France

  • Clinique Calabet

    Agen, 47000, France

  • Clinique Claude Bernard

    Albi, 81030, France

  • Clinique Pasteur - Département d'Oncologie Médicale

    Toulouse, 31076, France

  • Clinique Pasteur - Département de Radiothérapie

    Toulouse, 31300, France

  • Clinique Saint-Jean du Languedoc

    Toulouse, 31400, France

  • Clinique Tivoli

    Bordeaux, 33000, France

  • Hôpital Caremeau CHU Nîmes

    Nîmes, 30029, France

  • Hôpital Dupuytren CHU Limoges

    Limoges, 87042, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Polyclinique Bordeaux Nord

    Bordeaux, 33077, France

  • Polyclinique de l'Ormeau

    Tarbes, 65000, France