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Hope for breast cancer patients: new drug combo may delay recurrence

NCT ID NCT03820830

Disease control Sponsor: ETOP IBCSG Partners Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding the drug palbociclib to standard hormone therapy can help prevent breast cancer from coming back in people with a specific type of breast cancer (HR+/HER2-). About 405 participants who had surgery for a local or regional recurrence will receive either hormone therapy alone or hormone therapy plus palbociclib for 3 years. The study measures how long it takes for the cancer to return or for other health events to occur.

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

405 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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

Anyone

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. Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence of a primary invasive breast cancer in at least one of these sites: * breast; * the chest wall including mastectomy scar and/or skin; * axillary or internal mammary lymph nodes. 2. Completion of locoregional therapy: * completion of gross excision of recurrence within 6 months prior to randomization; * completion of radiotherapy (if given) more than 2 weeks prior to randomization 3. Negative or microscopically involved margins 4. Female or male aged 18 years or older 5. ECOG performance status 0 or 1 6. Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ ≥1% by IHC 7. Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified).Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH/FISH 8.-10. Normal hematological, renal, and liver function 11. The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ipsilateral isolated locoregional recurrence) available for submission for central pathology review 12. Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence 13.) Written Informed Consent prior to randomization Exclusion Criteria: 1. Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable 2. Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy or FDG-PET-CT). 3. Bilateral synchronous or metachronous invasive breast cancer (in situ carcinoma of the contralateral breast is allowed) 4. Inflammatory breast cancer 5. Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions: * Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible. * Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers. 6. Previous treatment with palbociclib or any other CDK 4/6 inhibitors 7. Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization) 8. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety 9. Pregnant or lactating women; lactation has to stop before randomization 10. Patients with psychiatric illness/social situations that would limit compliance with study requirements 11. Contraindications or known hypersensitivity to the palbociclib or excipients 12. History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer metastatic malignant neoplasm

As listed by the trial registrant

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

Breast cancer recurrent

Contacts and locations

Locations

  • AOU Maggiore Della Carita, University of Eastern Piedmont

    Novara, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, Italy

  • BZ Bethanien

    Zurich, 8001, Switzerland

  • Brust-Zentrum AG Zürich

    Zurich, Switzerland

  • Brustzentrum Basel Bethesda Spital

    Basel, Switzerland

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Hospitalier Universitaire de Limoges

    Limoges, 87000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Paul Strauss

    Strasbourg, France

  • Centre du Sein Fribourg

    Fribourg, Switzerland

  • Cro Irccs

    Aviano, Italy

  • Cêntre Hospitaler de Cholet

    Cholet, 49300, France

  • Fondazione Oncologia Lago Maggiore

    Locarno, Switzerland

  • Groupe hospitalier de Bretagne Sud, Hôpital du Scorff

    Lorient, France

  • Gustave Roussy

    Villejuif, 94800, France

  • HU Ramón y Cajal

    Madrid, Spain

  • Hospital General Universitario de Alicante

    Alicante, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Río Hortega

    Valladolid, Spain

  • Hospital Universitario Vall d´Hebrón

    Barcelona, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, Spain

  • Hospital Universitario de La Coruña

    A Coruña, Spain

  • Hospital Virgen de la Macarena

    Seville, Spain

  • Hospital Virgen de la Victoria

    Málaga, Spain

  • Hospital de Basurto

    Bilbao, Spain

  • ICM Val d'Aurelle

    Montpellier, 34298, France

  • Inselspital Bern

    Bern, Switzerland

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Català d´Oncología (ICO)

    Girona, Spain

  • Institut Claudius Regaud

    Toulouse, 31100, France

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Instituto Catalan de Oncologia L´Hospitalet

    Barcelona, Spain

  • Instituto Valenciano de Oncología (IVO)

    Valencia, Spain

  • Istituti Clinici Scientifici Maugeri

    Pavia, Italy

  • Istituto Europeo di Oncologia

    Milan, Italy

  • Istituto scientifico Romagnolo per lo studio e la cura

    Meldola, Italy

  • Kantonsspital Baden

    Baden, Switzerland

  • Kantonsspital Winterthur

    Winterthur, Switzerland

  • Kouros Moccia Oncologia

    Locarno, Switzerland

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • MUW - Universitätsklinik für Innere Medizin

    Vienna, Austria

  • Medizinische Universität Graz (MUG)

    Graz, Austria

  • Medizinische Universität Innsbruck - Univ.-Klinik f. Frauenheilkunde

    Innsbruck, Austria

  • National Institute of Oncology

    Budapest, Hungary

  • Ospedale S. Stefano

    Prato, Italy

  • PO Antonio Perrino Brindisi

    Brindisi, Italy

  • Polyclinique Bordeaux Nord

    Bordeaux, 333000, France

  • U.O. Oncologia, Ospedale Infermi

    Rimini, Italy

  • Uniklinikum Salzburg

    Salzburg, Austria

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