Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could thousands of women skip hormone therapy after breast cancer?

NCT ID NCT07661927

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This trial investigates whether women aged 60 and older with a very small, low-risk type of breast cancer can safely avoid hormone therapy after surgery. Participants will not receive standard drugs like tamoxifen or letrozole, and researchers will track cancer recurrence for up to five years. The goal is to see if skipping treatment maintains a low relapse rate while improving quality of life and reducing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
no endocrine therapy (omission of tamoxifen, letrozole, anastrozole, or exemestane)
What this could lead to
If successful, this could spare many older women the side effects of hormone therapy while maintaining a low risk of cancer returning.
What could go wrong
This is a single-arm Phase 2 trial, so results are compared to historical data. It may show that skipping therapy increases relapse risk or that the selected population is not as low-risk as assumed.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2033

An estimate. End dates often move.

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

60 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: * Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age. * New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam with no evidence of nodal or distant metastatic disease. * Contralateral breast described as BI-RADS (Breast Imaging-Reporting And Data System) 1 or 2 in diagnostic imaging. * Negative axillary node involvement by sentinel node biopsy or axillary node dissection (pN0) or Clinically negative axillary node involvement (cN0) after mandatory ultrasound exploration without surgical exploration of the axilla if Breast Conservative Surgery (BCS) was performed. * Estrogen Receptor (ER) positive (≥ 50%) and Progesterone Receptor(PR) positive (\> 20%), Ki67 low (≤15%) and HER2 negative (IHC or In Situ Hybridization approach) according to ASCO (American Society of Clinical Oncology) criteria. * Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b. * Treated by mastectomy or BCS with microscopically clear resection margins defined as "no-ink on tumor" or ≥1 mm for invasive and non-invasive disease or no residual disease on re-excision. * If BCS was performed, participants must have received or have scheduled adjuvant local radiotherapy (RT) within 3 months after surgery * No indication of adjuvant chemotherapy. * The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures. * Participants must be affiliated with a Social Security System (or equivalent). * The participant must have signed a written informed consent form before any trial-specific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant's consent in writing. Exclusion Criteria: * Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy. * Have received or are eligible for adjuvant chemotherapy. * Absolute contraindication for RT in case of BCS or patients who were treated with partial breast irradiation. * Have been treated with mastectomy and with adjuvant radiotherapy received or scheduled. * Invasive lobular breast cancer. * Bilateral breast cancer or history of other invasive ipsi- or contralateral breast cancer. * Multifocal or multicentric disease. * Disease limited to microinvasion only (\< 1 mm). * Evidence of lymphovascular invasion. * History of non-breast cancer malignancies if not disease-free for \> 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin. * Non-malignant severe disease associated with a life expectancy \< 10 years. * Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations. * Enrolled in another therapeutic study within 30 days prior to inclusion. * Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons. * Persons deprived of their liberty or under protective custody or guardianship.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer (early breast cancer) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer (early breast cancer)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annecy Genevois

    ACTIVE_NOT_RECRUITING

    Épagny, France

  • CH Aunay-Bayeux

    NOT_YET_RECRUITING

    Bayeux, France

  • CH Boulogne sur mer

    NOT_YET_RECRUITING

    Boulogne-sur-Mer, France

  • CH de Bligny

    NOT_YET_RECRUITING

    Briis-sous-Forges, France

  • CHCB

    NOT_YET_RECRUITING

    Bayonne, France

  • CHD Vendée

    NOT_YET_RECRUITING

    La Roche-sur-Yon, France

  • CHI de Mont-de-Marsan

    ACTIVE_NOT_RECRUITING

    Mont-de-Marsan, France

  • CHP Sainte Marie

    NOT_YET_RECRUITING

    Osny, France

  • CHU Orleans

    NOT_YET_RECRUITING

    Orléans, France

  • CHU Tours

    NOT_YET_RECRUITING

    Tours, France

  • CHU de Limoges

    NOT_YET_RECRUITING

    Limoges, France

  • CHU de Saint Etienne

    NOT_YET_RECRUITING

    Saint-Priest-en-Jarez, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, France

  • Centre Francois Baclesse

    NOT_YET_RECRUITING

    Caen, France

  • Centre Georges François Leclerc

    NOT_YET_RECRUITING

    Dijon, France

  • Centre Guillaume le Conquérant

    ACTIVE_NOT_RECRUITING

    Le Havre, France

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, France

  • Centre Jean Perrin

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Centre Leonard de Vinci

    NOT_YET_RECRUITING

    Dechy, France

  • Centre Léon Bérard

    ACTIVE_NOT_RECRUITING

    Lyon, France

  • Centre Oscar Lambret

    ACTIVE_NOT_RECRUITING

    Lille, France

  • Centre de lutte contre le cancer - Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, France

  • Clinique Pasteur Lanroze

    NOT_YET_RECRUITING

    Brest, France

  • Clinique Tivoli

    NOT_YET_RECRUITING

    Bordeaux, France

  • Groupe Hospitalier Bretagne Sud

    RECRUITING

    Lorient, France

  • Groupe Hospitalier Paris Saint Joseph

    NOT_YET_RECRUITING

    Paris, France

  • Groupe UNEOS-Hôpital Robert Schuman

    NOT_YET_RECRUITING

    Vantoux, France

  • Hôpital Privé Clairval

    NOT_YET_RECRUITING

    Marseille, France

  • Hôpital privé Jean Mermoz

    NOT_YET_RECRUITING

    Lyon, France

  • Hôpitaux du Léman

    NOT_YET_RECRUITING

    Thonon-les-Bains, France

  • IUCT-Oncopole

    NOT_YET_RECRUITING

    Toulouse, France

  • Ico Angers

    NOT_YET_RECRUITING

    Angers, France

  • Ico Saint Herblain

    NOT_YET_RECRUITING

    Saint-Herblain, France

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, France

  • Institut Curie

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Institut Curie

    NOT_YET_RECRUITING

    Saint-Cloud, France

  • Institut Paoli-Calmettes

    NOT_YET_RECRUITING

    Marseille, France

  • Institut de Cancérologie de Lorraine

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • Pole Sante Leonard de Vinci- Roc37

    NOT_YET_RECRUITING

    Chambray-lès-Tours, France

  • Sainte Catherine, Institut du Cancer Avignon-Provence

    NOT_YET_RECRUITING

    Avignon, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.