Gene test may spare young breast cancer patients from chemo

NCT ID NCT07106632

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study looks at whether a genetic test (Prosigna®) can help decide if younger women with early, hormone-sensitive breast cancer need chemotherapy. About 3380 premenopausal women will either get standard treatment (chemo plus hormone therapy) or a treatment plan based on the test results. The goal is to see if those with low genetic risk can safely skip chemo and use only hormone therapy, reducing side effects and preserving quality of life.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,380 people

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

Started

Jun 2026

Expected to finish

Aug 2038

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

35 to 45 years

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: 1. Patient must have signed a written informed consent 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 signing the patient's consent; 2. . Premenopausal defined by patient that are not post-menopaused 3. Female 4. Age ≥ 35 years 5. Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative/non-amplified ISH) invasive breast cancer; ER and HER2 determination will be assessed according to latest ASCO/CAP or national guidelines; 6. Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization; 7. Availability of a Formalin-Fixed Paraffin-Embedded (FFPE) tumour sample from surgery to perform Prosigna® analysis or slides. Note: in case of receipt of neoadjuvant endocrine therapy the Prosigna® test must be done on the baseline biopsy. Performing the test on the surgical piece or on on-treatment biopsy is not permitted. 8. Tumour size and axillary lymph node status. One of the following must apply: 1. 1-3 lymph nodes involved AND any invasive tumour size. 2. node negative (including micrometastases in at least 1 node \[i.e. deposit \>0.2-2mm diameter\]) AND invasive tumour size ≥ 50mm. 9. Multiple ipsilateral breast cancers are permitted provided that at least one tumour meets the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria. 10. Bilateral breast cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and/or HER2 positive and not clinically significant, defined by both of the following: 1. The contralateral tumour does not fulfil the tumour size and lymph node eligibility criteria required for trial entry; i.e. the following are not acceptable: .i. presence of lymph node macro-metastases; .ii. tumour size ≥50mm when there is no lymph node involvement. 2. The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy. 11. Fitness to receive adjuvant chemotherapy, as judged by the treating physician; 12. Short term pre-surgical treatment with endocrine therapy, including in combination with non-cytotoxic agents, is allowed providing that the duration of treatment did not exceed 8 weeks; 13. Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements 14. Patients must agree to use adequate contraception methods for the duration of study treatment and for the duration specified in the SmPC after completing the treatment, unless agreed with the treatment physician the safety of attempt a pregnancy, which could be possible after at least 18 months of endocrine therapy. Note : patient with extracapsular nodular transgression are eligible. NOTE: If neoadjuvant endocrine therapy was received, the Prosigna® test must be realized on the baseline biopsy. Performing the test on the surgical specimen or on biopsy taken during treatment is not permitted. NOTE: Re-excision or complementary mastectomy for close/positive surgical margins should be postponed after chemotherapy completion, if chemotherapy is given; breast reconstruction is allowed after trial entry. NOTE: The use of approved adjuvant targeted agents (abemaciclib, ribociclib and olaparib) combined to adjuvant endocrine therapy is allowed according to local practice recommendations and availability. Exclusion Criteria: * 1\. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal: 1. Age \>45 and natural amenorrhoea of at least 1 year's duration. 2. Bilateral surgical oophorectomy. 3. For amenorrhoea not fulfilling the above criteria the diagnosis of postmenopausal status should be supported by hormone measurement: FSH levels must be \> 25IU/L with low oestradiol (i.e. within the locally defined postmenopausal range), in the event of doubt measured on 2 occasions preferably 4-6 weeks apart. This applies to women who have undergone hysterectomy without bilateral surgical oophorectomy and are age \<60; those ≥60 may be considered postmenopausal. NOTE: Hormonal contraception will suppress FSH and oestradiol levels. In those taking oral contraception, levels will recover rapidly on discontinuation. Depo-Provera injectable contraception lasts many months: all women receiving this agent should be considered premenopausal. 2\. Stage IV breast cancer; 3. Start of adjuvant systemic treatment (except for neoadjuvant endocrine therapy for a duration ≤ 8 weeks) before trial entry\*; 4. Previous diagnosis of malignancy except:  1. Previous ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (LCIS) of the breast managed by local treatment only; 2. Previous in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia; 3. Previous invasive malignancy managed by local treatment only AND disease-free for at least 10 years. 5\. Patients enrolled in another therapeutic trial within 30 days of inclusion; 6. Presence of concomitant medical and/or psychiatric comorbidities and/or social problems that might prevent informed consent, treatment compliance or follow up; 7. Person deprived of their liberty or under protective custody or guardianship. 8\. Pregnant women or women who are breast-feeding at inclusion. 9. Patients unwilling or unable to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures because of geographic, familial, social, or psychological reasons. \*Trial entry is dated from of the date the participant signs the consent form or provides remote verbal consent, whichever is earlier.

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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.

Early breast cancer HR+ HER2- breast cancer Premenopausal breast cancer

How to take part

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

The places running it

105 sites in 7 countries. The list below names each one and where it is.
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 ↗
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

"OSPEDALE P. PEDERZOLI" Casa di Cura Privata S.p.A.
NOT_YET_RECRUITING

Peschiera del Garda, 37019, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia
NOT_YET_RECRUITING

Perugia, 06132, Italy
A.O.U Policlinico di Modena
NOT_YET_RECRUITING

Modena, 41124, Italy
A.O.U. Federico II - Policlinico
NOT_YET_RECRUITING

Naples, 80131, Italy
A.O.U. Policlinico Umberto I
NOT_YET_RECRUITING

Roma, 00161, Italy
A.O.U. di Parma
NOT_YET_RECRUITING

Parma, 43126, Italy
ASS Territoriale Papa Giovanni XXIII
NOT_YET_RECRUITING

Bergamo, 24127, Italy
ASST Lecco - P.O. A. Manzoni
NOT_YET_RECRUITING

Lecco, 23900, Italy
ASST Ospedale Maggiore di Crema
NOT_YET_RECRUITING

Crema, 26013, Italy
AUSL - IRCCS di Reggio Emilia
NOT_YET_RECRUITING

Reggio Emilia, 420123, Italy
AUSL Della Romagna
NOT_YET_RECRUITING

Ravenna, 48121, Italy
AUSL della Romagna - Ospedale Infermi di Rimini
NOT_YET_RECRUITING

Rimini, 47923, Italy
AUSL di Modena - Ospedale B. Ramazzini
NOT_YET_RECRUITING

Carpi, 41012, Italy
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
NOT_YET_RECRUITING

Manresa, 08243, Spain
Avicenne Hospital (APHP)
RECRUITING

Bobigny, 93000, France
Azienda Ospedaliero Universitaria Careggi
NOT_YET_RECRUITING

Florence, 50134, Italy
CH Annecy Genevois
NOT_YET_RECRUITING

Épagny Metz-Tessy, 74370, France
CH Cholet
RECRUITING

Cholet, 49300, France
CHR Verviers
NOT_YET_RECRUITING

Verviers, 4800, Belgium
CHU Helora Hôpital de La Louvière - Site Jolimont
NOT_YET_RECRUITING

Haine-Saint-Paul, 7100, Belgium
CHU Tours
RECRUITING

Tours, 37000, France
CHU UCL Namur - Site Sainte Elisabeth
NOT_YET_RECRUITING

Namur, 5000, Belgium
CHU de Limoges
NOT_YET_RECRUITING

Limoges, 87042, France
CHU de Saint Etienne
RECRUITING

Saint-Priest-en-Jarez, 42000, France
CLCC Eugène Marquis
RECRUITING

Rennes, 35042, France
Centre Francois Baclesse
NOT_YET_RECRUITING

Caen, 14000, France
Centre Georges François Leclerc
NOT_YET_RECRUITING

Dijon, 21000, France
Centre Henri Becquerel
RECRUITING

Rouen, 76000, France
Centre Hospitalier Fleyriat Bourg en Bresse
NOT_YET_RECRUITING

Bourg-en-Bresse, 01012, France
Centre Hospitalier Intercommunal de Fréjus Saint Raphael
RECRUITING

Fréjus, 83600, France
Centre Hospitalier Le Mans - Centre De Cancérologie De La Sarthe
NOT_YET_RECRUITING

Le Mans, 72000, France
Centre Hospitalier Métropole Savoie
RECRUITING

Chambéry, 73000, France
Centre Hospitalier Simone Veil de Beauvais
RECRUITING

Beauvais, 60021, France
Centre Hospitalier d'Auxerre
RECRUITING

Auxerre, 89000, France
Centre Hospitalier de Pau
RECRUITING

Pau, 64000, France
Centre Hospitalier de la Côte Basque
NOT_YET_RECRUITING

Bayonne, 64100, France
Centre Jean Perrin
NOT_YET_RECRUITING

Clermont-Ferrand, 63011, France
Centre Léon Bérard
RECRUITING

Lyon, 69008, France
Centre Léonard De Vinci
RECRUITING

Dechy, 59187, France
Centre Oscar Lambret
NOT_YET_RECRUITING

Lille, 59000, France
Centre de cancérologie Les Dentellières
RECRUITING

Valenciennes, 59300, France
Centro Di Riferimento Oncologico Di Aviano
NOT_YET_RECRUITING

Aviano, 33081, Italy
Clinique Mutualiste de l'Estuaire
NOT_YET_RECRUITING

Saint-Nazaire, 44600, France
Clinique Médico Chirurgicale Charcot
NOT_YET_RECRUITING

Sainte-Foy-lès-Lyon, 69110, France
Clinique Pasteur
RECRUITING

Toulouse, 31076, France
Clinique Pasteur - CFRO
RECRUITING

Brest, 29200, France
Clinique Saint Pierre
NOT_YET_RECRUITING

Ottignies, 1340, Belgium
Clinique Tivoli
NOT_YET_RECRUITING

Bordeaux, 33000, France
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING

Brussels, 1200, Belgium
Consorcio Hospitalario Provincial De Castellon
NOT_YET_RECRUITING

Castillón, 12006, Spain
Cork University Hospital
NOT_YET_RECRUITING

Cork, T12 DC4A, Ireland
Fondazione IRCCS Istituto Nazionale Dei Tumori
NOT_YET_RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING

Roma, 00168, Italy
Grand Hôpital de Charleroi
NOT_YET_RECRUITING

Charleroi, B-6060, Belgium
Groupe Hospitalier Mutualiste de Grenoble
RECRUITING

Grenoble, 38028, France
Groupement Hospitalier Est - Hospices Civils de Lyon
NOT_YET_RECRUITING

Bron, 69500, France
Hospital Clinic De Barcelona
NOT_YET_RECRUITING

Barcelona, 08036, Spain
Hospital General Universitario De Valencia
NOT_YET_RECRUITING

Valencia, 46014, Spain
Hospital General Universitario Dr. Balmis
NOT_YET_RECRUITING

Alicante, 03010, Spain
Hospital Universitario Ramon Y Cajal
NOT_YET_RECRUITING

Madrid, 28034, Spain
Hospital Universitario Virgen De La Macarena
NOT_YET_RECRUITING

Seville, 41009, Spain
Hospital Universitario Virgen De Las Nieves
NOT_YET_RECRUITING

Granada, 18014, Spain
Hygeia Hospital
NOT_YET_RECRUITING

Athens, GR 151 23, Greece
Hôpital Européen
NOT_YET_RECRUITING

Marseille, 13003, France
Hôpital Lyon Sud-Hospices Civils de Lyon
NOT_YET_RECRUITING

Pierre-Bénite, 69495, France
Hôpital NOVO - Site de Pontoise
NOT_YET_RECRUITING

Pontoise, 95300, France
Hôpital Privé Clairval
NOT_YET_RECRUITING

Marseille, 13009, France
Hôpital Privé Nancy Lorraine
NOT_YET_RECRUITING

Nancy, 54000, France
Hôpital Privé du Confluent
RECRUITING

Nantes, 44277, France
Hôpital de Blois
NOT_YET_RECRUITING

Blois, 41000, France
Hôpital de la croix Rousse - Hospices Civils de Lyon
NOT_YET_RECRUITING

Lyon, 69004, France
Hôpitaux du Léman
RECRUITING

Thonon-les-Bains, 74200, France
IASO Hospital
NOT_YET_RECRUITING

Athens, GR 151 23, Greece
IRCCS Istituto Nazionale Tumori Fondazione Pascale
NOT_YET_RECRUITING

Naples, 80131, Italy
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"
NOT_YET_RECRUITING

Meldola, 47014, Italy
IRCCS Ospedale Policlinico San Martino
NOT_YET_RECRUITING

Genova, 16132, Italy
IRCCS San Gerardo
NOT_YET_RECRUITING

Monza, 20900, Italy
Institut Godinot
RECRUITING

Reims, 51100, France
Institut Gustave Roussy
RECRUITING

Villejuif, 94800, France
Institut Jules Bordet
NOT_YET_RECRUITING

Brussels, 1070, Belgium
Institut Paoli Calmettes
NOT_YET_RECRUITING

Marseille, 13009, France
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, 54519, France
Instytut Centrum Zdrowia Matki Polki
NOT_YET_RECRUITING

Lodz, 93-338, Poland
Istituto Oncologico Veneto
NOT_YET_RECRUITING

Padova, 35128, Italy
Klinika Onkologii I Radioterapii Universeryteckie Centrum Kliniczne- Gdansk
NOT_YET_RECRUITING

Gdansk, 80-214, Poland
MSC National Research Institute Of Oncology
NOT_YET_RECRUITING

Gliwice, 44-102, Poland
Mater Misericordiae University Hospital
NOT_YET_RECRUITING

Dublin, D07 A8NN, Ireland
Mater Private Hospital
NOT_YET_RECRUITING

Dublin, D07 WKW8, Ireland
Metropolitan Hospital
NOT_YET_RECRUITING

Athens, GR 185 47, Greece
Midland Regional Hospital Tullamore
NOT_YET_RECRUITING

Tullamore, R35 NY51, Ireland
Militray Institute of Medicine
NOT_YET_RECRUITING

Warsaw, 04-141, Poland
Oncology Clinic, University Clinical Hospital in Pozan, Medical University
NOT_YET_RECRUITING

Poznan, 60-569, Poland
Oncopole Claudius Regaud, IUCT-Oncopole
RECRUITING

Toulouse, 31059, France
Pôle Santé République
NOT_YET_RECRUITING

Clermont-Ferrand, 63000, France
Sainte Catherine - Institut du Cancer Avignon-Provence
RECRUITING

Avignon, 84918, France
St James's Hospital
NOT_YET_RECRUITING

Dublin, D08 NHY1, Ireland
Strasbourg Oncologie Libérale - Clinique Sainte Anne
NOT_YET_RECRUITING

Strasbourg, 67000, France
University General Hospital 'Attikon'
NOT_YET_RECRUITING

Athens, GR 124 62, Greece
University Hospital 'Aretaieio'
NOT_YET_RECRUITING

Athens, GR 115 28, Greece
University Hospital Limerick
NOT_YET_RECRUITING

Limerick, V94 F858, Ireland
University Hospital Son Espases
NOT_YET_RECRUITING

Palma, 07120, Spain
University Hospital Virgen Del Rocio
NOT_YET_RECRUITING

Seville, 41013, Spain
University Hospital Waterford
NOT_YET_RECRUITING

Waterford, X91 ER8E, Ireland
ZP ZOZ Opolskie Centrum Onkologii im.prof. Tadeusza Koszarowskiego
NOT_YET_RECRUITING

Opole, 45-061, Poland
Zachodniopomorskie Centrum Onkologii
NOT_YET_RECRUITING

Szczecin, 71-730, Poland

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