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Gene test guides breast cancer treatment switch in major trial

NCT ID NCT03079011

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new strategy for people with a common type of advanced breast cancer (ER+, HER2-). It used a blood test to look for a gene change (ESR1 mutation) that can make cancer stop responding to the first hormone therapy. When the mutation appeared, some patients switched to a different hormone drug (fulvestrant) while continuing palbociclib. The goal was to see if this switch could keep the cancer under control longer and to check the safety of the drug combination. About 1,017 people took part in this phase 3 trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

1,017 people

The number who actually took part.

Started

Mar 2017

Finished

Sep 2025

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

18 years and older

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. Women with proven loco-regionally recurrent or metastatic adenocarcinoma of the breast not amenable to curative therapy with disease considered potentially sensitive to aromatase inhibitors Note: patients relapsing while on adjuvant tamoxifen or other non-aromatase inhibitor adjuvant endocrine therapy and patients relapsing more than one year after the end of aromatase inhibitor adjuvant therapy are eligible for the present study; 2. Age ≥18 years; 3. Life expectancy \>3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; 5. Estrogen Receptor (ER)-positive and HER2-negative breast cancer. Where available, assessment of Estrogen Receptor status should be based on the most recent tumor sample; to be considered as ER-positive, the most recent breast cancer tissue examined must display at least 10% of cancer cells with positive ER staining; 6. Tumor block (primary tumor or metastasis) available; 7. No prior systemic anti-cancer therapy for metastatic or advanced disease (chemotherapy, targeted therapy or hormone therapy); prior initiation of LHRH agonist or bone-directed agents is however allowed); 8. Menopausal patients or patients with suppressed ovarian function * Women with bilateral oophorectomy * Postmenopausal women, as defined by any of the following criteria: * Age 60 or over; * Age 50 to 59 years and meets one of the following criteria: * Amenorrhea for ≥24 months and follicle-stimulating hormone within the postmenopausal range; * patients with hysterectomy or chemotherapy-induced amenorrhea must display follicle-stimulating hormone within the postmenopausal range; * Other women, provided they are being treated with monthly LHRH analogues (first injection performed ≥7 days before the treatment initiation) and are willing to continue to receive LHRH agonist therapy for the duration of the trial; 9. Patients may have measurable (according to Response Evaluation Criterion in Solid Tumors (RECIST v1.1) or not measurable disease * Patients with only blastic bone lesions are not eligible; * Patients with only pleural, cardiac or peritoneal effusion or meningeal carcinomatosis are not eligible; 10. Adequate organ and marrow function as defined below: * Hemoglobin ≥90 g/L * Absolute neutrophil count ≥1.5 g/L * Platelet count ≥100 g/L * Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome. * ALT and AST ≤3 × ULN; * Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN if bone or liver metastases present) * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥ 60 mL/min as determined by Cockcroft-Gault (using actual body weight) formula for females \[creatinine clearance =Weight (kg) × (140 - Age) × 0.85 (mL/min)/ (72 × serum creatinine (mg/dL)) 11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations; 12. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.03 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion); 13. Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations; 14. Patient affiliated to a social security system. Exclusion Criteria: 1. Locally advanced breast cancer or loco-regional relapse amenable for any treatment with curative intent; 2. Her2-positive or equivocal tumor status either on the primary or on the recurrent tumor, defined as IHC3+, Fish/Cish amplified or Fish/Cish equivocal according to the ASCO2015 criteria; 3. Prior endocrine therapy in the metastatic setting is not allowed; 4. Prior treatment with any CDK 4/6 inhibitor in the adjuvant or metastatic setting (neoadjuvant/preoperative treatment is allowed); however, prior therapy with another targeted treatment in the adjuvant setting is allowed; 5. Visceral crisis: Advanced, symptomatic, visceral spread that is at risk of life-threatening complication in the short term and that requires chemotherapy; 6. Any major surgery (defined as requiring general anaesthesia) or significant traumatic injury within 4 weeks of treatment initiation or patients that may require major surgery during the course of the study; however, surgical diagnostic procedure is allowed (even if performed under general anaesthesia); 7. Known, active bleeding diathesis; 8. Any serious known concomitant systemic disorder (e.g. known active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti-coagulation treatment (the use of low molecular weight heparin is allowed); 9. Patients unable to swallow tablets; 10. History of mal-absorption syndrome or other condition that would interfere with enteral absorption; 11. Chronic daily treatment with corticosteroids with a dose of ≥10 mg/day methylprednisolone equivalent (excluding inhaled steroids); 12. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral oedema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable and off anticonvulsants and steroids for at least 4 weeks before treatment start; 13. Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant, palbociclib or any of their excipients; 14. Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia); 15. Patients treated within the last 7 days prior to treatment start in the trial with drug that are known to be CYP3A4 inhibitors, drugs that are known to be CIP3A4 inducers, who underwent a grapefruit cure; 16. Patients already included in another therapeutic trial evaluating an investigational medicinal product or having received an investigational medicinal product within 3 months; 17. History of previous: * Any other stage II, III, IV cancer within 5 years preceding patient enrollment in the trial - however, multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumor masses were ER+; * Any history of hematological malignancy; 18. Persons deprived of their freedom or under guardianship or incapable of giving consent; 19. Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LHRH agonist cannot be considered as an efficient contraceptive measure) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

Contacts and locations

Locations

  • CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

    Plérin, France

  • CH Mont de Marsan

    Mont-de-Marsan, France

  • CH William Morey

    Chalon-sur-Saône, France

  • CHI Fréjus St-Raphaël

    Fréjus, France

  • CHP Saint Grégoire

    Saint-Grégoire, France

  • CHRU Morvan

    Brest, France

  • CHU Dupuytren

    Limoges, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Catalan d'Oncologie

    Perpignan, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Francois Baclesse

    Caen, France

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier ANNECY GENEVOIS

    Metz-Tessy, France

  • Centre Hospitalier Bretagne Atlantique

    Vannes, France

  • Centre Hospitalier Bretagne Sud

    Lorient, France

  • Centre Hospitalier Départemental de Vendée

    La Roche-sur-Yon, France

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Hospitalier Montceau les mines

    Montceau-les-Mines, France

  • Centre Hospitalier Métropole de Savoie

    Chambéry, France

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, France

  • Centre Hospitalier Saint-Brieuc

    Saint-Brieuc, France

  • Centre Hospitalier Universitaire

    Amiens, France

  • Centre Hospitalier d'Auxerre

    Auxerre, France

  • Centre Hospitalier de Beauvais

    Beauvais, France

  • Centre Hospitalier de Blois

    Blois, France

  • Centre Hospitalier de Broussais

    St-Malo, France

  • Centre Hospitalier de Cholet

    Cholet, France

  • Centre Hospitalier de Cornouaille

    Quimper, France

  • Centre Hospitalier de Pau

    Pau, France

  • Centre Hospitalier de Tours - Hopital Bretonneau

    Tours, France

  • Centre Hospitalier de Versailles

    Le Chesnay, France

  • Centre Hospitalier de boulogne sur Mer

    Boulogne-sur-Mer, France

  • Centre Hospitalier le Mans

    Le Mans, France

  • Centre Hôpital Sainte Marie

    Chalon-sur-Saône, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Leon Berard

    Lyon, France

  • Centre ONCOGARD - Institut de Cancérologie du Gard

    Nîmes, France

  • Centre Paul Stauss

    Strasbourg, France

  • Centre d'Oncologie de Gentilly

    Nancy, France

  • Centre d'Oncologie radiothérapie de Macon

    Mâcon, France

  • Centre de radiothérapie et d'oncologie médicale LE-CROME

    Ris-Orangis, France

  • Clinique Claude Bernard

    Metz, France

  • Clinique François Chénieux

    Limoges, France

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, France

  • Clinique PASTEUR-CFRO

    Brest, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Sainte Anne

    Strasbourg, France

  • Clinique Tivoli Ducos

    Bordeaux, France

  • Clinique de l'Europe

    Amiens, France

  • Clinique de l'Orangerie

    Strasbourg, France

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, France

  • Clinique de la Sauvegarde

    Lyon, France

  • Clinique du Cap d'Or

    La Seyne-sur-Mer, France

  • Gustave Roussy

    Villejuif, 94805, France

  • Hopital Diaconesses-Croix Saint Simon

    Paris, France

  • Hopital Européen Georges Pompidou

    Paris, France

  • Hopital Privé du Confluent

    Nantes, France

  • Hôpital Européen Marseille

    Marseille, France

  • Hôpital Saint Joseph

    Marseille, France

  • Hôpital privé Jean Mermoz

    Lyon, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

  • Hôpitaux du Léman

    Thonon-les-Bains, France

  • ICM - Val d'Aurelle

    Montpellier, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie

    Paris, 75005, France

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, France

  • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, France

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret, France

  • Institut Paoli Calmettes

    Marseille, France

  • Institut Sainte Catherine

    Avignon, France

  • Institut de Cancérologie de l'Ouest - Site Paul Papin

    Angers, France

  • Institut de Cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain, France

  • Institut de cancérologie lucien Neuwith

    Saint-Priest-en-Jarez, France

  • Medipole de Savoie

    Challes-les-Eaux, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, France

  • Polyclinique Francheville

    Périgueux, France

  • Pôle Santé République

    Clermont-Ferrand, France

  • Saint Louis Hospital

    Paris, France

  • UNEOS Site Hôpital Robert Schuman

    Vantoux, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.