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Breast cancer drug showdown: which CDK4/6 inhibitor works best?

NCT ID NCT05207709

Disease control Sponsor: SOLTI Breast Cancer Research Group 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial aimed to compare two drugs, ribociclib and palbociclib, in people with a specific type of advanced breast cancer (HR+/HER2- with HER2-enriched features). Participants received one of the drugs combined with hormone therapy. The goal was to see which combination better delays cancer growth. The study was terminated early and enrolled only 61 of the planned 456 participants, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ribociclib and palbociclib (both combined with hormone therapy)
What this could lead to
If ribociclib proves better, it could become the preferred treatment for this type of advanced breast cancer, potentially delaying disease progression.
What could go wrong
The trial was terminated early with only 61 participants, so results are limited and may not be conclusive. Both drugs are already approved, so any advantage may be modest.

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

61 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

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

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.

Main Inclusion Criteria: * Histologically documented HR-positive and HER2-negative breast cancer by local testing * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer. * Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period. * HER2-E or Basal-like subtype as per central PAM50 analysis. * Measurable disease or non-measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end-organ function * Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. * Women of childbearing potential must have confirmed negative serum pregnancy test within 7 days prior to randomization. * Women of CBP must be willing to use highly effective methods of contraception. * Patient must have a 6-lead or 12-lead ECG with ALL of the following parameters at screening: * QTcF interval (QT interval using Fridericia's correction) at screening \< 450 msec. * Resting heart rate 50-90 beats per minute (determined from the ECG). Main Exclusion Criteria: * Prior therapy with any CDK4/6 inhibitors. * Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer

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Conditions

The condition(s) this trial relates to.

basal-like breast carcinoma breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • Baptist Memorial Health Care

    Oxford, Mississippi, 38655, United States

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 231136, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Centro Hospitalar Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502, Portugal

  • Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050, Spain

  • Complejo Asistencial Universitario de León

    León, León, 24001, Spain

  • Complejo Hospitalario San Pedro de Alcántara

    Cáceres, 10003, Spain

  • Dana Faber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Clinical Oncology

    Kettering, Ohio, 45429, United States

  • Edwards Comprehensive Cancer Center

    Huntington, Virginia, 25701, United States

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040, Spain

  • H. Clínico San Cecilio de Granada

    Granada, 18016, Spain

  • Hospital Beatriz Ângelo

    Loures, 2674-514, Portugal

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza, 50009, Spain

  • Hospital Clínico Universitario de A Coruña

    A Coruña, La Coruña, 15006, Spain

  • Hospital Clínico Universitario de Santiago CHUS

    Santiago de Compostela, La Coruña, 15706, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Hospital La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Quiron Salud Sagrado Corazon Sevilla

    Seville, Sevilla, 41013, Spain

  • Hospital Sant Joan de Reus

    Reus, 43204, Spain

  • Hospital Senhora da Oliveira - Guimarães

    Creixomil, Portugal

  • Hospital Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Morales Meseguer

    Murcia, Murcia, 30008, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41013, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, 38320, Spain

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas, 35010, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Virgen de la Macarena

    Seville, 41007, Spain

  • Hospital Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital de Basurto

    Bilbao, 48013, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • IOB-Institute of Oncology. Hospital Quironsalud Barcelona

    Barcelona, Barcelona, 8023, Spain

  • IPO Lisboa

    Lisbon, 1500-650, Portugal

  • Institut Català d' Oncologia (ICO Badalona)

    Badalona, Barcelona, 08916, Spain

  • Institut Català d' Oncologia de Girona (ICO Girona)

    Girona, Girona, 17007, Spain

  • Institut Català d'Oncologia (ICO Hospitalet)

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009, Spain

  • Legacy Good Samaritan Hospital and Medical Cente

    Portland, Oregon, 97210, United States

  • Memorial Regional Hospital

    Hollywood, Florida, 33021, United States

  • Montefiore

    The Bronx, New York, 10467, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mount Sinai Florida

    Miami, Florida, 33140, United States

  • NHOH

    Londonderry, New Hampshire, 03053, United States

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89121, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • Nothwell Health

    New York, New York, 11042-1069, United States

  • Novant Health Care

    Winston-Salem, North Carolina, 27103, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97225, United States

  • Sinai of Baltimore

    Baltimore, Maryland, 21215, United States

  • The Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • University of Kentucky, Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Miami

    Coral Gables, Florida, 33124, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina Lineberger

    Chapel Hill, North Carolina, 27514, United States

  • Unv. Wisconsin

    Madison, Wisconsin, 53792, United States

  • Upstate Carolina Medical Center

    Spartanburg, South Carolina, 29302, United States

  • Vall d´Hebron University Hospital

    Barcelona, 08035, Spain

More trials for these conditions

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