Actively Recruiting
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
Led by UNICANCER · Updated on 2026-03-16
3902
Participants Needed
70
Research Sites
628 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+/HER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ /HER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4/6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.
CONDITIONS
Official Title
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed written informed consent prior to any trial-specific screening.
- Female patients aged 18 years or older.
- Known menopausal status at time of randomization, with post-menopausal defined by surgery, age, or hormone levels.
- Histologically confirmed invasive breast cancer with specific pathological stages including pT2 pN0 Grade 3 or Grade 2 with Ki67 20%, or pT0-2 pN1, or pT3-4 pN0.
- Tumors must be estrogen receptor-positive (at least 10% staining) and HER2-negative.
- Eligible for chemotherapy based on investigator decision using clinical or genomic criteria.
- Planned to receive adjuvant endocrine therapy for 5 years or more.
- Curative surgery performed with negative margins within 12 weeks before randomization, or planned revision/local treatment if margins are positive.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Women of childbearing potential agree to use effective contraception during treatment and for 21 days after last dose.
- ECOG performance status of 0 or 1 within 28 days prior to randomization.
- Adequate blood counts, liver and kidney function as specified.
- QTcF interval less than 450 milliseconds and resting heart rate between 50-100 bpm on ECG.
- Willing and able to comply with study visits, treatments, and procedures.
- No psychological, familial, or geographical conditions that may prevent compliance.
- Affiliated with a social security system or equivalent according to local regulations.
You will not qualify if you...
- Prior neoadjuvant chemotherapy or previous CDK4/6 inhibitor treatment.
- Breast cancer diagnosed during use of tamoxifen, raloxifene, or aromatase inhibitors for risk reduction or osteoporosis treatment within 2 years.
- Known allergy to ribociclib or endocrine therapy components.
- Evidence or history of distant metastases beyond regional lymph nodes, inflammatory breast cancer, recurrence, or a second primary breast cancer.
- Concurrent or recent invasive malignancy within 2 years, except certain skin or cervical cancers.
- Breast cancer considered insensitive to endocrine therapy.
- Major surgery within 14 days before treatment start.
- HIV infection with interacting antiretroviral therapy or uncontrolled HIV.
- Active hepatitis B or C infection.
- Significant uncontrolled heart disease or abnormalities including recent heart attack, cardiomyopathy, low heart function, long QT syndrome, serious arrhythmias, or uncontrolled hypertension.
- Medical conditions that contraindicate experimental drug use or risk safety, such as severe respiratory or metabolic dysfunction.
- History of pneumonitis.
- Use of medications or supplements that strongly interact with ribociclib within 7 days before randomization.
- Concurrent hormone replacement therapy or recent estrogen replacement.
- Recent or ongoing systemic corticosteroids use, except short courses or topical/inhaled forms.
- Any severe uncontrolled medical condition posing safety risks or limiting life expectancy to 5 years or less.
- Participation in conflicting clinical studies within 30 days or 5 half-lives of investigational drugs.
- Inability or unwillingness to swallow oral pills.
- Malabsorption syndrome or conditions affecting drug absorption.
- Psychological, familial, sociological, or geographical factors impeding study adherence.
- Pregnant or breastfeeding women or those planning pregnancy or breastfeeding during first 48 months of therapy.
- Persons deprived of liberty or under protective custody or guardianship.
AI-Screening
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Trial Site Locations
Total: 70 locations
1
Clinique de l'Europe
Amiens, France, 80090
Not Yet Recruiting
2
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers, France, 49055
Not Yet Recruiting
3
CH Victor Dupouy
Argenteuil, France, 95107
Not Yet Recruiting
4
CH Henri Mondor
Aurillac, France, 15000
Active, Not Recruiting
5
Centre Hospitalier d'Auxerre
Auxerre, France
Not Yet Recruiting
6
Sainte Catherine - Institut du Cancer Avignon Provence
Avignon, France, 84918
Active, Not Recruiting
7
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Not Yet Recruiting
8
Centre Hospitalier Simone Veil de Beauvais
Beauvais, France, 60021
Active, Not Recruiting
9
Centre Hospitalier Universitaire de Besancon
Besançon, France, 25000
Not Yet Recruiting
10
Institut Bergonie
Bordeaux, France, 33076
Not Yet Recruiting
11
Clinique Tivoli
Bordeaux, France
Not Yet Recruiting
12
Centre Francois Baclesse
Caen, France, 14000
Not Yet Recruiting
13
Centre Hospitalier de Carcassonne
Carcassonne, France, 11000
Not Yet Recruiting
14
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Active, Not Recruiting
15
Centre Hospitalier Métropole de Savoie
Chambéry, France, 73000
Not Yet Recruiting
16
Centre d'Oncologie et de Radiothérapie 37
Chambray-lès-Tours, France, 37170
Not Yet Recruiting
17
CH Cholet
Cholet, France, 49300
Not Yet Recruiting
18
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
19
Hospices Civils de Colmar
Colmar, France, 68000
Not Yet Recruiting
20
Polyclinique Saint Côme
Compiègne, France, 60200
Not Yet Recruiting
21
Clinique de Flandre
Coudekerque-Branche, France, 59210
Not Yet Recruiting
22
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
Not Yet Recruiting
23
CHI Fréjus St-Raphaël
Fréjus, France
Not Yet Recruiting
24
Polyclinique de Blois
La Chaussée-Saint-Victor, France, 41260
Not Yet Recruiting
25
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, France, 85925
Not Yet Recruiting
26
CHU Grenoble
La Tronche, France
Not Yet Recruiting
27
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Not Yet Recruiting
28
Centre Hospitalier le Mans
Le Mans, France, 72000
Not Yet Recruiting
29
Clinique Victor Hugo
Le Mans, France, 72000
Not Yet Recruiting
30
Polyclinique de Limoges - Site Cinique Chénieux
Limoges, France, 87039
Not Yet Recruiting
31
Centre Hospitalier Universitaire de Limoges
Limoges, France, 87042
Not Yet Recruiting
32
Centre Leon Berard
Lyon, France, 69008
Active, Not Recruiting
33
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Active, Not Recruiting
34
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
35
Centre Hospitalier Annecy Genevois
Metz-Tessy, France
Not Yet Recruiting
36
Centre de Cancerologie du Grand Montpellier
Montpellier, France, 34070
Not Yet Recruiting
37
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace (GHRMSA)
Mulhouse, France, 68100
Not Yet Recruiting
38
Hopital Privé du Confluent
Nantes, France
Not Yet Recruiting
39
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
40
CHU de NÎMES - Institut de Cancérologie du Gard
Nîmes, France, 30029
Not Yet Recruiting
41
CHU Orléans
Orléans, France
Not Yet Recruiting
42
Hopital Saint Louis
Paris, France, 75010
Not Yet Recruiting
43
Hopital Diaconesses-Croix Saint Simon
Paris, France, 75020
Not Yet Recruiting
44
Hôpital Tenon APHP
Paris, France, 75020
Not Yet Recruiting
45
Centre Hospitalier de Pau
Pau, France, 64046
Not Yet Recruiting
46
Hospices Civils de Lyon - Centre principal: Hôpital Lyon Sud
Pierre-Bénite, France
Not Yet Recruiting
47
CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologie
Plérin, France
Not Yet Recruiting
48
CHU Poitiers
Poitiers, France, 86180
Not Yet Recruiting
49
Hôpital NOVO - Site PONTOISE
Pontoise, France, 95300
Not Yet Recruiting
50
Centre Hospitalier de Quimper
Quimper, France, 29000
Not Yet Recruiting
51
Clinique de la Croix du Sud
Quint-Fonsegrives, France, 31130
Not Yet Recruiting
52
Institut Jean Godinot
Reims, France, 51100
Not Yet Recruiting
53
Centre Eugène Marquis
Rennes, France, 35042
Not Yet Recruiting
54
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
55
Institut Curie
Saint-Cloud, France, 92219
Actively Recruiting
56
Hôpital Privé de la Loire
Saint-Etienne, France, 42100
Not Yet Recruiting
57
CHU de Saint Étienne
Saint-Etienne, France, 42270
Not Yet Recruiting
58
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, France, 44800
Not Yet Recruiting
59
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France, 44600
Not Yet Recruiting
60
Institut de Cancérologie Paris Nord - GCS RISSA
Sarcelles, France, 95200
Not Yet Recruiting
61
Groupe Hospitalier Rance Emeraude (GHRE)
St-Malo, France, 35400
Not Yet Recruiting
62
Centre Paul Stauss
Strasbourg, France
Active, Not Recruiting
63
Hôpitaux du Léman
Thonon-les-Bains, France, 74200
Not Yet Recruiting
64
Institut Claudius Regaud
Toulouse, France, 31059
Active, Not Recruiting
65
CHU Bretonneau
Tours, France, 37000
Not Yet Recruiting
66
Centre Hospitalier de Valence
Valence, France, 26000
Not Yet Recruiting
67
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Active, Not Recruiting
68
Gustave Roussy
Villejuif, France
Not Yet Recruiting
69
Institut Paoli Calmettes
Marseille, Île-de-France Region, France, 13009
Not Yet Recruiting
70
Institut Curie
Paris, Île-de-France Region, France, 75005
Not Yet Recruiting
Research Team
S
Sandrine Marques
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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