Breast Cancer (Early Breast Cancer)Phase 2NoELANCT07661927
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
A Phase 2 study testing Removing Endocrine Therapy in people with Breast Cancer (Early Breast Cancer), run by UNICANCER at 41 sites in France.
Trial summary
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer)
- What is being tested?
- Removing Endocrine Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 41 sitesFrance
- Study dates
- 6 Jul 2026to 6 Jul 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
France41 sites, 30 recruiting
- Not yet recruiting
Ico Angers
Angers
Dr PATSOURIS
- Active, not recruiting
Sainte Catherine, Institut du Cancer Avignon-Provence
Avignon
- Not yet recruiting
CH Aunay-Bayeux
Bayeux
Dr BRACHET
- Active, not recruiting
CHCB
Bayonne
- Not yet recruiting
Clinique Tivoli
Bordeaux
Dr GARBAY
- Not yet recruiting
Institut Bergonié
Bordeaux
Dr PETIT
- Active, not recruiting
CH Boulogne sur mer
Boulogne-sur-Mer
- Active, not recruiting
Clinique Pasteur Lanroze
Brest
- Not yet recruiting
CH de Bligny
Briis-sous-Forges
Dr MERIC
- Not yet recruiting
Centre Francois Baclesse
Caen
Dr EMILE
- Recruiting
Pole Sante Leonard de Vinci- Roc37
Chambray-lès-Tours
Dr BERNADOU
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand
Dr MOURET-REYNIER
- Active, not recruiting
Centre Leonard de Vinci
Dechy
- Not yet recruiting
Centre Georges François Leclerc
Dijon
Pr LADOIRE
- Active, not recruiting
CH Annecy Genevois
Épagny
- Recruiting
CHD Vendée
La Roche-sur-Yon
Dr LEGOUTE
- Recruiting
Centre Guillaume le Conquérant
Le Havre
Dr PEREIRA
- Recruiting
Centre Oscar Lambret
Lille
Dr KACZMAREK
- Not yet recruiting
CHU de Limoges
Limoges
Pr DELUCHE
- Recruiting
Groupe Hospitalier Bretagne Sud
Lorient
Dr BERTHET
- Recruiting
Centre Léon Bérard
Lyon
Dr KLINGER
- Active, not recruiting
Hôpital privé Jean Mermoz
Lyon
- Not yet recruiting
Hôpital Privé Clairval
Marseille
Dr PAOLI
- Not yet recruiting
Institut Paoli-Calmettes
Marseille
Pr GONCALVES
- Active, not recruiting
CHI de Mont-de-Marsan
Mont-de-Marsan
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Dr GROULIER
- Active, not recruiting
CHU Orleans
Orléans
- Not yet recruiting
CHP Sainte Marie
Osny
Dr BLEICHNER
- Not yet recruiting
Groupe Hospitalier Paris Saint Joseph
Paris
Dr SIMONAGGIO
- Recruiting
Institut Curie
Paris
Pr PIERGA
- Recruiting
Centre Eugène Marquis
Rennes
Dr PERRIN
- Not yet recruiting
Centre Henri Becquerel
Rouen
Dr VITUCCI
- Recruiting
Institut Curie
Saint-Cloud
Dr BELLO ROUFAI
- Not yet recruiting
Ico Saint Herblain
Saint-Herblain
Dr FRENEL
- Active, not recruiting
CHU de Saint Etienne
Saint-Priest-en-Jarez
- Active, not recruiting
Centre de lutte contre le cancer - Paul Strauss
Strasbourg
- Not yet recruiting
Hôpitaux du Léman
Thonon-les-Bains
Dr CIOBANU
- Recruiting
IUCT-Oncopole
Toulouse
Pr DALENC
- Not yet recruiting
CHU Tours
Tours
Dr LARRIVIERE
- Not yet recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Dr CHARRA-BRUNAUD
- Not yet recruiting
Groupe UNEOS-Hôpital Robert Schuman
Vantoux
Dr BENNA
About this study
Official title: No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.
All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.
Read the detailed description
Breast cancer is the most frequently diagnosed cancer among women worldwide. Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) tumors represent the predominant subtype and are generally associated with favorable outcomes. Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors, constitutes a cornerstone of treatment for HR+/HER2- early breast cancer and has demonstrated reductions in recurrence and mortality in large randomized trials and meta-analyses. However, these benefits were mainly established in populations including patients with a broader spectrum of recurrence risk.
The implementation of mammography screening programs has increased the detection of small, early-stage breast cancers, including tumors with excellent prognosis and very low risk of recurrence. In postmenopausal women with small node-negative Luminal A tumors, recurrence rates are particularly low, raising concerns regarding potential overtreatment and the balance between treatment benefit and toxicity.
Although ET is effective, its long-term administration is associated with substantial treatment burden and persistent toxicities, including musculoskeletal symptoms, vasomotor symptoms, fatigue, sexual dysfunction, mood disturbances, and bone loss. These adverse effects may significantly affect quality of life and contribute to treatment discontinuation. Observational data have suggested that ET-related quality-of-life impairment may persist longer than chemotherapy-related effects, particularly in postmenopausal women.
Retrospective studies have suggested that the absolute benefit of ET may be limited in selected patients with very low-risk disease, especially among older women with small, low-grade HR+/HER2- tumors. Furthermore, simulation models estimating individualized treatment benefit indicate that the absolute overall survival gain associated with ET in some low-risk subgroups may be minimal, with high numbers needed to treat.
Advances in biological characterization have enabled identification of Luminal A tumors, characterized by strong hormone receptor expression, low proliferative activity, and favorable prognosis. Combining biological characteristics with clinicopathological features such as age, tumor size, grade, and nodal status allows the identification of a subgroup of postmenopausal patients with exceptionally low risk of relapse.
NoELA was developed to prospectively evaluate a therapeutic de-escalation strategy consisting of omission of adjuvant ET in postmenopausal women presenting with very low-risk HR+/HER2- early breast cancer with Luminal A phenotype. The study focuses on patients expected to derive limited benefit from ET while remaining exposed to its long-term toxicity burden.
The study also aims to generate evidence supporting more individualized treatment strategies and improved shared decision-making by better quantifying the risk-benefit balance of ET omission in this population. In addition, comparison with external real-world data derived from patients treated with standard ET will help contextualize outcomes and improve the external validity of the findings.
- Conditions
- Breast Cancer (Early Breast Cancer)
- Being tested
- Removing Endocrine Therapy
- Keywords
- breast cancer, hormone therapy, de-escalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removing Endocrine TherapyDrug
The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.
| Study group | Role | What they receive |
|---|---|---|
| No Endocrine Therapy | Experimental | The endocrine therapy will not be received by the participant during the study. Receives: Drug: Removing Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free interval
Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., J Clin Oncol 2021)
Measured: At 5 years after the last treatment
Secondary outcomes (9)
Incidence of Ipsilateral Ductal Carcinoma In Situ (DCIS)
Measured: At 5 years after the last treatment
Incidence of invasive contralateral breast cancer
Measured: At 5 years after the last treatment
Distant disease free survival (DDFS)
Distant disease free survival is defined as the delay between date of inclusion and distant tumor relapse or death from any cause, whichever occurs first.
Measured: At 5 years after the last treatment
Relapse free survival (RFS)
Relapse-free survival is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Measured: 5 years after the last treatment
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Measured: At 5 years after the last treatment
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, 6 months, 1 year, and then annually until 5 years after the last inclusion
Quality of Life Questionnaire - Breast cancer module (QLQ-BR42)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR42 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items.
Measured: At baseline, 6 months, 1 year, and then annually until 5 year after the last inclusion
Hospital anxiety and depression scale (HADS)
The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.
Measured: At baseline, 6 months, 1 year, and then annually until 5 year after the last inclusion
Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 6 (NCI-CTCAE v6) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: Throughout study completion, up to 5 years after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start6 Jul 2026
- Primary completion6 Jul 2033 (estimated)
- Study completion6 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Jean-Yves PIERGA, MD, Principal investigator, Institut CurieJosé Luis SANDOVAL, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661927
- Sponsor's protocol ID
- UC-BCG-2513
- Other IDs
- 2025-523683-20-00, 2025
- Acronym
- NoELA
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
- ClinicalTrials.gov ID
- NCT07661927
- Acronym / sponsor ID
- NoELA / UC-BCG-2513
- Conditions
- Breast Cancer (Early Breast Cancer)
- Keywords
- breast cancer, hormone therapy, de-escalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Swiss Cancer Institute
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 6 Jul 2033 (estimated)
- Study completion
- 6 Jul 2033 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.
All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.
Detailed description
Breast cancer is the most frequently diagnosed cancer among women worldwide. Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) tumors represent the predominant subtype and are generally associated with favorable outcomes. Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors, constitutes a cornerstone of treatment for HR+/HER2- early breast cancer and has demonstrated reductions in recurrence and mortality in large randomized trials and meta-analyses. However, these benefits were mainly established in populations including patients with a broader spectrum of recurrence risk.
The implementation of mammography screening programs has increased the detection of small, early-stage breast cancers, including tumors with excellent prognosis and very low risk of recurrence. In postmenopausal women with small node-negative Luminal A tumors, recurrence rates are particularly low, raising concerns regarding potential overtreatment and the balance between treatment benefit and toxicity.
Although ET is effective, its long-term administration is associated with substantial treatment burden and persistent toxicities, including musculoskeletal symptoms, vasomotor symptoms, fatigue, sexual dysfunction, mood disturbances, and bone loss. These adverse effects may significantly affect quality of life and contribute to treatment discontinuation. Observational data have suggested that ET-related quality-of-life impairment may persist longer than chemotherapy-related effects, particularly in postmenopausal women.
Retrospective studies have suggested that the absolute benefit of ET may be limited in selected patients with very low-risk disease, especially among older women with small, low-grade HR+/HER2- tumors. Furthermore, simulation models estimating individualized treatment benefit indicate that the absolute overall survival gain associated with ET in some low-risk subgroups may be minimal, with high numbers needed to treat.
Advances in biological characterization have enabled identification of Luminal A tumors, characterized by strong hormone receptor expression, low proliferative activity, and favorable prognosis. Combining biological characteristics with clinicopathological features such as age, tumor size, grade, and nodal status allows the identification of a subgroup of postmenopausal patients with exceptionally low risk of relapse.
NoELA was developed to prospectively evaluate a therapeutic de-escalation strategy consisting of omission of adjuvant ET in postmenopausal women presenting with very low-risk HR+/HER2- early breast cancer with Luminal A phenotype. The study focuses on patients expected to derive limited benefit from ET while remaining exposed to its long-term toxicity burden.
The study also aims to generate evidence supporting more individualized treatment strategies and improved shared decision-making by better quantifying the risk-benefit balance of ET omission in this population. In addition, comparison with external real-world data derived from patients treated with standard ET will help contextualize outcomes and improve the external validity of the findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Endocrine Therapy | Experimental | Drug: Removing Endocrine TherapyThe endocrine therapy will not be received by the participant during the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removing Endocrine TherapyThe standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study. | Drug | No Endocrine Therapy |
Primary outcome
Relapse-free interval
Time frame: At 5 years after the last treatment
Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., J Clin Oncol 2021)
9 secondary outcomes
Incidence of Ipsilateral Ductal Carcinoma In Situ (DCIS)
Time frame: At 5 years after the last treatment
Incidence of invasive contralateral breast cancer
Time frame: At 5 years after the last treatment
Distant disease free survival (DDFS)
Time frame: At 5 years after the last treatment
Relapse free survival (RFS)
Time frame: 5 years after the last treatment
Overall survival (OS)
Time frame: At 5 years after the last treatment
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, 6 months, 1 year, and then annually until 5 years after the last inclusion
Quality of Life Questionnaire - Breast cancer module (QLQ-BR42)
Time frame: At baseline, 6 months, 1 year, and then annually until 5 year after the last inclusion
Hospital anxiety and depression scale (HADS)
Time frame: At baseline, 6 months, 1 year, and then annually until 5 year after the last inclusion
Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0
Time frame: Throughout study completion, up to 5 years after the last inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Yves PIERGA, MD principal investigator
Institut Curie
José Luis SANDOVAL, MD principal investigator
University Hospital, Geneva
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Removing Endocrine Therapy in people with Breast Cancer (Early Breast Cancer), run by UNICANCER at 41 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Unicancer Project Leader (0033 6 58 43 58 94, a-poitou@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free interval (time frame: At 5 years after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.