Could two years of hormone therapy be enough for some breast cancers?
NCT ID NCT05297617
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study tests whether postmenopausal women with a very low-risk type of breast cancer (HR+ HER2-) can safely take hormone therapy for only 2-3 years instead of the standard 5 years. The goal is to maintain protection against cancer spread while reducing side effects and improving quality of life. Participants receive one of three aromatase inhibitors daily.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an aromatase inhibitor (letrozole, anastrozole, or exemestane)
- What this could lead to
- If successful, this could show that a shorter course of hormone therapy is safe for women with very low-risk breast cancer, sparing them years of side effects.
- What could go wrong
- This is a single-arm Phase 2 trial without a comparison group, so results may not be definitive. Shorter therapy might still carry a small risk of distant recurrence.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 696 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Nov 2035
An estimate. End dates often move.
- Lead sponsor
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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
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51 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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. Postmenopausal women: Postmenopausal status is defined by any of the following: * Prior bilateral oophorectomy * Age ≥60 years * Age \>50 and \<60 years and amenorrheic for at least 12 months, and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 3. Women with histologically proven invasive unilateral breast cancer Note: In case of a multifocal invasive tumor, all lesions (maximum 3 infiltrating lesions allowed) must be of identical phenotype and low biological risk 4. M0: Not clinically nor radiologically detectable metastases at time of inclusion 5. Primary tumor completely resected and adequate axillary surgery performed, according to current standards 6. IHC expression of the estrogen receptor and/or progesterone receptor ≥50% 7. HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH nonamplified\]) 8. No indication of adjuvant chemotherapy 9. pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2 Note 1: patient with Grade 2 pT2pN0 tumor must be aged under 70 years of age and should receive a genomic test as part of standard care (RIHN reimbursement) 10. Patient considered has having a luminal A ultralow risk of metastatic recurrence (i.e.less than 5% risk of metastatic relapse at 10 years) according to MammaPrint® and Blueprint® tests. Note 1: To be eligible, MammaPrint index score should be \> +0.355 11. Patients eligible to receive or have recently started (with a maximum of 4 months of adjuvant hormone therapy prior to enrollment) an adjuvant hormone therapy (letrozole, anastrozole, or exemestane) 12. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures 13. Patients must be affiliated to a Social Security System (or equivalent) 14. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. Exclusion Criteria: 1. Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment 2. Any local or regional recurrence or metastatic disease 3. Non-invasive carcinoma 4. Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer 5. Patients with a history of another malignancy, except for properly treated cervical carcinoma in situ, and non-melanoma cancer of the skin 6. Women with high-risk breast cancer predisposing deleterious germline mutations 7. Contra-indications to the administration of anti-aromatase inhibitors 8. Patients enrolled in another therapeutic study within 30 days prior to inclusion 9. Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment 10. Patients unwilling or unable to comply with trial obligations for geographic, social, physical or psychological reasons, or who are unable to understand the purpose and procedures of the trial 11. Persons deprived of their liberty or under protective custody or guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier Universitaire de Limoges
RECRUITINGLimoges, 87042, France
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Institute Gustave Roussy
NOT_YET_RECRUITINGVillejuif, 94805, France
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