Skipping Hormone Therapy in Low-Risk Early Breast Cancer
NoELA
No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
2 other identifiers
interventional
700
1 country
41
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2026
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 6, 2033
July 17, 2026
May 1, 2026
7 years
May 22, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
At 5 years after the last treatment
Secondary Outcomes (9)
Incidence of Ipsilateral Ductal Carcinoma In Situ (DCIS)
At 5 years after the last treatment
Incidence of invasive contralateral breast cancer
At 5 years after the last treatment
Distant disease free survival (DDFS)
At 5 years after the last treatment
Relapse free survival (RFS)
5 years after the last treatment
Overall survival (OS)
At 5 years after the last treatment
- +4 more secondary outcomes
Study Arms (1)
No Endocrine Therapy
EXPERIMENTALThe endocrine therapy will not be received by the participant during the study.
Interventions
The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- Swiss Cancer Institutecollaborator
Study Sites (41)
Ico Angers
Angers, France
Sainte Catherine, Institut du Cancer Avignon-Provence
Avignon, France
CH Aunay-Bayeux
Bayeux, France
CHCB
Bayonne, France
Clinique Tivoli
Bordeaux, France
Institut Bergonié
Bordeaux, France
CH Boulogne sur mer
Boulogne-sur-Mer, France
Clinique Pasteur Lanroze
Brest, France
CH de Bligny
Briis-sous-Forges, France
Centre Francois Baclesse
Caen, France
Pole Sante Leonard de Vinci- Roc37
Chambray-lès-Tours, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Leonard de Vinci
Dechy, France
Centre Georges François Leclerc
Dijon, France
CH Annecy Genevois
Épagny, France
CHD Vendée
La Roche-sur-Yon, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, France
Groupe Hospitalier Bretagne Sud
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital privé Jean Mermoz
Lyon, France
Hôpital Privé Clairval
Marseille, France
Institut Paoli-Calmettes
Marseille, France
CHI de Mont-de-Marsan
Mont-de-Marsan, France
Centre Antoine Lacassagne
Nice, France
CHU Orleans
Orléans, France
CHP Sainte Marie
Osny, France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Institut Curie
Paris, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut Curie
Saint-Cloud, France
Ico Saint Herblain
Saint-Herblain, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
Centre de lutte contre le cancer - Paul Strauss
Strasbourg, France
Hôpitaux du Léman
Thonon-les-Bains, France
IUCT-Oncopole
Toulouse, France
CHU Tours
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Groupe UNEOS-Hôpital Robert Schuman
Vantoux, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Yves PIERGA, MD
Institut Curie
- PRINCIPAL INVESTIGATOR
José Luis SANDOVAL, MD
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2026
First Posted
June 22, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
July 6, 2033
Study Completion (Estimated)
July 6, 2033
Last Updated
July 17, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.