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New hope for stage IV breast cancer: adding surgery or radiation to targeted therapy

NCT ID NCT03870919

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether adding surgery or radiation to a standard drug combination (palbociclib plus letrozole) can help people with newly diagnosed stage IV ER+/HER2- breast cancer live longer. About 200 women with cancer that has spread beyond the breast will receive the drug combo, and some will also get local treatment on their breast tumor. The goal is to see if this combined approach improves overall survival compared to drugs alone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Oct 2027

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

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 newly diagnosed and histologically proven de novo adenocarcinoma of the breast, Any T, any N, with at least one metastatic site measurable and/or non-measurable according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 and/or PET Response Criteria in Solid Tumours (PERCIST) v1.0 and/or MD Anderson bone response criteria (MDA criteria). For patients with only bone metastases, at least one lytic and non-irradiated lesion must be present NB: Bilateral breast cancer is allowed only if tumours present similar histological criteria (morphological subtype, ER and HER2 status). 2. Estrogen Receptor (ER)-positive and HER2-negative breast cancer. To be considered as ER-positive, the biopsy of the primary tumour must display at least 10% of cancer cells with positive ER staining. HER2-positive is defined as IHC3+ or FISH/CISH amplified according to 2018 criteria 3. Age ≥18 years 4. Eastern Cooperative Oncology Group (ECOG) ≤2 5. Indication for treatment with palbociclib and letrozole (with or without ovarian suppression) 6. Diagnostic FFPE tumour sample and/or frozen primary breast tumour sample available 7. Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before inclusion 8. Patients must agree to use adequate contraception methods for the duration of the study and for within 21 days after completing treatment 9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including absence of co-morbidities preventing surgery and or radiotherapy and any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the patient before registration in the trial 10. Patient affiliated to a social security system 11. Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations Exclusion Criteria: 1. Patients with advanced, symptomatic, visceral spread at a risk for short-term, life-threatening complications according to investigator judgement and at risk for visceral crisis as defined by ABC4\* 2. Women with previously diagnosed and treated ipsilateral adenocarcinoma of the breast 3. Women with previously treated or concomitant contralateral breast cancer except for Ductal carcinoma in situ (DCIS) treated with curative intent 4. Patients with another concomitant cancer 5. Concurrent enrolment in another clinical trial in which investigational therapies are administered or administration of an investigational drug within 30 days before inclusion 6. Pregnant women or women who are breast-feeding 7. Inability or willingness to swallow oral medication 8. HIV, hepatitis (B and C) 9. Active infection 10. Prior therapy for metastatic breast cancer (systemic or local) 11. Persons deprived of their freedom or under guardianship or incapable of giving consent * Visceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since another treatment option at progression will probably not be possible.

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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.

Breast cancer stage IV Radiotherapy Surgery

Contacts and locations

Locations

  • CH Cholet

    Cholet, 49300, France

  • CH René Dubos

    Pontoise, 95000, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre François Baclesse

    Caen, France

  • Centre George François Leclerc

    Dijon, 21000, France

  • Centre Hospitalier de Pau

    Pau, 64000, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63000, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • GCS RISSA - Institut de cancérologie Paris Nord

    Sarcelles, 95200, France

  • Gustave Roussy

    Villejuif, 94800, France

  • Hôpital Privé à Saint Grégoire

    Saint-Grégoire, 35760, France

  • Hôpital Saint Louis APHP

    Paris, 75010, France

  • Hôpital St Joseph

    Marseille, 13008, France

  • Hôpital St Joseph

    Paris, 75014, France

  • Hôpital Tenon

    Paris, 75020, France

  • Hôpital privé sainte Marie

    Chalon-sur-Saône, 71100, France

  • Hôpital saint Eloi CHU Montpellier

    Montpellier, 34090, France

  • ICM Val d'Aurelle

    Montpellier, 34298, France

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Curie Hôpital René Huguenin

    Saint-Cloud, 92210, France

  • Institut Curie Site Paris

    Paris, 75005, France

  • Institut Jean Godinot

    Reims, 51726, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut Sainte Catherine

    Avignon, 84818, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

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

    Angers, 49005, France

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