Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
OPTIMA-YOUNG
Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women
4 other identifiers
interventional
3,380
7 countries
105
Brief Summary
Rationale: Around 70 to 80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work. For post-menopausal women, genetic tests exist to assess whether chemotherapy is really necessary in addition to hormonal treatment. However, for high-risk premenopausal patients, chemotherapy is still systematically recommended, as no study has proved that it can be safely avoided. Clinical trials based on risk stratification using genetic tests have not been conclusive, but the majority of premenopausal women included had not received optimal hormone treatment. It is possible that the beneficial effect of chemotherapy is partly due to the artificial menopause it induces. Some experts believe that, for patients with a high clinical risk but a low genetic risk, an optimised hormonal treatment (drug + OFS) could suffice, without the need for chemotherapy. Objectives: Main objective: The aim of the study is to determine whether the use of a genetic test (Prosigna®) to decide whether or not to administer chemotherapy produces results as good as standard treatment (systematic chemotherapy) in premenopausal women with hormone-dependent (HR+) breast cancer/HER2-, by assessing their risk of cancer recurrence. The secondary objectives include verifying whether, in patients with a low Prosigna® score (around 70% of cases), optimised hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy combined with hormonal in treatment preventing cancer recurrence. The study also seeks to compare the efficacy of treatment Prosigna®-guided versus systematic chemotherapy in terms of recurrence and quality of life, as well as economic aspects. Finally, the aim is to understand patients' concerns about the concept of reducing treatment (therapeutic de-escalation) and the way in which this information is communicated to them. The primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer. This includes the return of cancer in the same breast or neighbouring areas, the spread of cancer to other parts of the body, the appearance of new cancer in the other breast or death from any cause. Trial Population: The study includes women major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer. Patients must have undergone breast and axillary surgery recent and have a tumour sample suitable for analysis by the testProsigna® . They must be able to receive the study treatments Postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment (except short neoadjuvant hormone therapy), women with a recent history of invasive cancer, pregnant women or women who are breast-feeding will not be able to take part in the study. Interventions: After agreeing to take part, patients will enter the pre-inclusion period (up to 28 days before randomisation), during which the investigator will carry out all the necessary tests to assess their eligibility. The investigator will then randomise the patients to find out which treatment they have been assigned, no more than 2 weeks later: the experimental group will receive a treatment decided on the basis of the results of a genomic test: either chemotherapy and hormone therapy, or hormone therapy alone. The control group will receive the standard treatment. The treatment and follow-up phases are the same as for standard care. Information on the quality of life patient's will and other information (associated costs, perception of their participation in the study, etc.) also be collected by means of questionnaires completed by the patients during the 5 years following randomisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Longer than P75 for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedStudy Start
First participant enrolled
June 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2038
July 31, 2026
July 1, 2026
5.1 years
June 11, 2025
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
invasive breast cancer free survival (IBCFS)
Invasive Breast Cancer Free Survival (IBCFS), is defined according to the STEEP version 2.0 system (Tolaney et al., JCO 2021) as the time from the date of randomization to the date of the first event of ipsilateral loco-regional invasive breast cancer recurrence, distant breast cancer recurrence, contralateral new invasive primary breast cancer or death from any cause.
Time from the date of randomization to the date of the first event (ipsilateral loco-regional invasive breast or distant breast cancer recurrence, contralateral new invasive primary breast cancer or death from any cause), assessed up to 120 months
Secondary Outcomes (33)
Invasive Breast Cancer Free Survival (IBCFS) in the population with tumours for which the Prosigna® score is below 60
Time from the date of randomization to the date of the first event (ipsilateral loco-regional invasive breast or distant breast cancer recurrence, contralateral new invasive primary breast cancer or death from any cause), assessed up to 120 months
Distant recurrence free interval (DRFI)
time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from breast cancer in the global population, assessed up to 120 months
Distant recurrence free survival (DRFS)
time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from any cause in the global population, assessed up to 120 months
Breast cancer specific survival (BCSS)
time from the date of randomization to the date of death from breast cancer in the global population, assessed up to 120 months
Overall survival (OS)
time from the date of randomization to the date of death from any cause in the global population, assessed up to 120 months
- +28 more secondary outcomes
Study Arms (2)
Control Arm
ACTIVE COMPARATORExperimental Arm
EXPERIMENTALInterventions
In this experimental arm, the treatment is driven by the score of the Prosigna test. If the score is superior to 60, the patient is considered at hight risk so the patient will receive chemo-endocrine therapy. If the result is under or equal to 60, only endocrine therapy will be prescribed to the patient.
Standard treatment: Chemotherapy followed by endocrine therapy
Eligibility Criteria
You may qualify if:
- 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;
- Premenopausal defined by patient that are not post-menopaused
- Female
- Age ≥ 35 years
- 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;
- Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization;
- 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.
- Tumour size and axillary lymph node status. One of the following must apply:
- lymph nodes involved AND any invasive tumour size.
- node negative (including micrometastases in at least 1 node \[i.e. deposit \>0.2-2mm diameter\]) AND invasive tumour size ≥ 50mm.
You may not qualify if:
- 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:
- 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.
- The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy.
- Fitness to receive adjuvant chemotherapy, as judged by the treating physician;
- 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;
- Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements
- 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.
- \. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal:
- Age \>45 and natural amenorrhoea of at least 1 year's duration.
- Bilateral surgical oophorectomy.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- University of Warwickcollaborator
Study Sites (105)
Institut Jules Bordet
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Grand Hôpital de Charleroi
Charleroi, B-6060, Belgium
CHU Helora Hôpital de La Louvière - Site Jolimont
Haine-Saint-Paul, 7100, Belgium
CHU UCL Namur - Site Sainte Elisabeth
Namur, 5000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
CHR Verviers
Verviers, 4800, Belgium
Centre Hospitalier d'Auxerre
Auxerre, 89000, France
Sainte Catherine - Institut du Cancer Avignon-Provence
Avignon, 84918, France
Centre Hospitalier de la Côte Basque
Bayonne, 64100, France
Centre Hospitalier Simone Veil de Beauvais
Beauvais, 60021, France
Hôpital de Blois
Blois, 41000, France
Avicenne Hospital (APHP)
Bobigny, 93000, France
Clinique Tivoli
Bordeaux, 33000, France
Centre Hospitalier Fleyriat Bourg en Bresse
Bourg-en-Bresse, 01012, France
Clinique Pasteur - CFRO
Brest, 29200, France
Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500, France
Centre Francois Baclesse
Caen, 14000, France
Centre Hospitalier Métropole Savoie
Chambéry, 73000, France
CH Cholet
Cholet, 49300, France
Pôle Santé République
Clermont-Ferrand, 63000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Léonard De Vinci
Dechy, 59187, France
Centre Georges François Leclerc
Dijon, 21000, France
CH Annecy Genevois
Épagny Metz-Tessy, 74370, France
Centre Hospitalier Intercommunal de Fréjus Saint Raphael
Fréjus, 83600, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
Centre Hospitalier Le Mans - Centre De Cancérologie De La Sarthe
Le Mans, 72000, France
Centre Oscar Lambret
Lille, 59000, France
CHU de Limoges
Limoges, 87042, France
Hôpital de la croix Rousse - Hospices Civils de Lyon
Lyon, 69004, France
Centre Léon Bérard
Lyon, 69008, France
Hôpital Européen
Marseille, 13003, France
Hôpital Privé Clairval
Marseille, 13009, France
Institut Paoli Calmettes
Marseille, 13009, France
Hôpital Privé Nancy Lorraine
Nancy, 54000, France
Hôpital Privé du Confluent
Nantes, 44277, France
Centre Hospitalier de Pau
Pau, 64000, France
Hôpital Lyon Sud-Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Hôpital NOVO - Site de Pontoise
Pontoise, 95300, France
Institut Godinot
Reims, 51100, France
CLCC Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76000, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, 42000, France
Clinique Médico Chirurgicale Charcot
Sainte-Foy-lès-Lyon, 69110, France
Strasbourg Oncologie Libérale - Clinique Sainte Anne
Strasbourg, 67000, France
Hôpitaux du Léman
Thonon-les-Bains, 74200, France
Oncopole Claudius Regaud, IUCT-Oncopole
Toulouse, 31059, France
Clinique Pasteur
Toulouse, 31076, France
CHU Tours
Tours, 37000, France
Centre de cancérologie Les Dentellières
Valenciennes, 59300, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94800, France
University Hospital 'Aretaieio'
Athens, GR 115 28, Greece
University General Hospital 'Attikon'
Athens, GR 124 62, Greece
Hygeia Hospital
Athens, GR 151 23, Greece
IASO Hospital
Athens, GR 151 23, Greece
Metropolitan Hospital
Athens, GR 185 47, Greece
Cork University Hospital
Cork, T12 DC4A, Ireland
Mater Misericordiae University Hospital
Dublin, D07 A8NN, Ireland
Mater Private Hospital
Dublin, D07 WKW8, Ireland
St James's Hospital
Dublin, D08 NHY1, Ireland
University Hospital Limerick
Limerick, V94 F858, Ireland
Midland Regional Hospital Tullamore
Tullamore, R35 NY51, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Centro Di Riferimento Oncologico Di Aviano
Aviano, 33081, Italy
ASS Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
AUSL di Modena - Ospedale B. Ramazzini
Carpi, 41012, Italy
ASST Ospedale Maggiore di Crema
Crema, 26013, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
ASST Lecco - P.O. A. Manzoni
Lecco, 23900, Italy
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"
Meldola, 47014, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, 20133, Italy
A.O.U Policlinico di Modena
Modena, 41124, Italy
IRCCS San Gerardo
Monza, 20900, Italy
A.O.U. Federico II - Policlinico
Naples, 80131, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131, Italy
Istituto Oncologico Veneto
Padova, 35128, Italy
A.O.U. di Parma
Parma, 43126, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia
Perugia, 06132, Italy
"OSPEDALE P. PEDERZOLI" Casa di Cura Privata S.p.A.
Peschiera del Garda, 37019, Italy
AUSL Della Romagna
Ravenna, 48121, Italy
AUSL - IRCCS di Reggio Emilia
Reggio Emilia, 420123, Italy
AUSL della Romagna - Ospedale Infermi di Rimini
Rimini, 47923, Italy
A.O.U. Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Klinika Onkologii I Radioterapii Universeryteckie Centrum Kliniczne- Gdansk
Gdansk, 80-214, Poland
MSC National Research Institute Of Oncology
Gliwice, 44-102, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
ZP ZOZ Opolskie Centrum Onkologii im.prof. Tadeusza Koszarowskiego
Opole, 45-061, Poland
Oncology Clinic, University Clinical Hospital in Pozan, Medical University
Poznan, 60-569, Poland
Zachodniopomorskie Centrum Onkologii
Szczecin, 71-730, Poland
Militray Institute of Medicine
Warsaw, 04-141, Poland
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Clinic De Barcelona
Barcelona, 08036, Spain
Consorcio Hospitalario Provincial De Castellon
Castillón, 12006, Spain
Hospital Universitario Virgen De Las Nieves
Granada, 18014, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Manresa, 08243, Spain
University Hospital Son Espases
Palma, 07120, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
University Hospital Virgen Del Rocio
Seville, 41013, Spain
Hospital General Universitario De Valencia
Valencia, 46014, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ines Vaz-Luis
Gustave Roussy, Cancer Campus, Grand Paris
Central Study Contacts
Vanhecke
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
August 6, 2025
Study Start
June 26, 2026
Primary Completion (Estimated)
August 15, 2031
Study Completion (Estimated)
August 15, 2038
Last Updated
July 31, 2026
Record last verified: 2026-07