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New drug combo shows promise for tough breast cancer

NCT ID NCT03310957

Disease control Sponsor: Seagen Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combination of two drugs, ladiratuzumab vedotin and pembrolizumab, in 185 people with advanced triple-negative breast cancer that had spread. The main goals were to check for side effects and see how well the drugs shrank tumors. The trial was completed and provides information on safety and effectiveness of this treatment approach.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

185 people

The number who actually took part.

Started

Feb 2018

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) * Part D only: Tumor tissue PD-L1 Combined Positive Score \<10 expression. * Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer * At least 6 months since prior treatment with curative intent and recurrence * At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Able to provide biopsy tissue for biomarker analysis * Meet baseline laboratory data criteria Exclusion Criteria: * Prior immune-oncology therapy * Pre-existing neuropathy of at least Grade 2 * History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids. * Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy * Active autoimmune disease requiring systemic treatment within the past 2 years * History of interstitial lung disease * Current pneumonitis or history of pneumonitis requiring steroids

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative breast neoplasms

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804, United States

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407, United States

  • CHA Bundang Medical Center

    Seongnam, Other, 13496, South Korea

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048, United States

  • Chao Family Comprehensive Cancer Center University of California Irvine

    Orange, California, 92868, United States

  • Complejo Hospitalario Universitario La Coruna

    A Coruña, Other, 15006, Spain

  • Complejo Hospitalario de Jaen

    Jaén, Other, 23007, Spain

  • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98109-1023, United States

  • Gynakologisches Zentrum Bonn Friedensplatz

    Bonn, Other, 53111, Germany

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • HM Centro Integral Oncologico Clara Campal

    Madrid, Other, 28050, Spain

  • Helen F. Graham Cancer Center / Christiana Care Health Systems

    Newark, Delaware, 19713, United States

  • Hospital Ruber Internacional

    Madrid, Other, 28034, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Other, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Other, 28041, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Other, 28223, Spain

  • Hospital del Mar

    Barcelona, Other, 08003, Spain

  • Ingalls Cancer Care / Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

    Essen, Other, 45136, Germany

  • Klinikum Rechts der Isar der Technischen Universitaet Muenchen

    München, Other, 81675, Germany

  • Klinikum der Universitat Munchen

    München, 80337, Germany

  • Korea Cancer Center Hospital

    Seoul, Other, 01802, South Korea

  • L'Institut Catala d'Oncologia

    L'Hospitalet de Llobregat, Other, 08907, Spain

  • MD Anderson Cancer Center - Madrid

    Madrid, Other, 28033, Spain

  • Marien Hospital Bottrop

    Bottrop, Other, 46236, Germany

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176, United States

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87131, United States

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30309, United States

  • Pusan National University Hospital

    Busan, Other, 49201, South Korea

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012, United States

  • Rotkreuzklinikum Munich

    Munich, Other, 80637, Germany

  • Saint Luke's Cancer Institute LLC

    Kansas City, Missouri, 64111, United States

  • Samsung Medical Center

    Seoul, Other, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Other, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Other, 03722, South Korea

  • Stadtisches Klinikum Dessau

    Dessau, Other, 06847, Germany

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Texas Oncology - DFW

    Dallas, Texas, 75246, United States

  • Texas Oncology - Houston Memorial City

    Houston, Texas, 77024, United States

  • Texas Oncology - San Antonio Medical Center Northeast

    San Antonio, Texas, 78212, United States

  • The Whittingham Cancer Center / Norwalk Hospital

    Norwalk, Connecticut, 06856, United States

  • Universitatsklinikum Erlangen

    Erlangen, Other, 91054, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California Irvine - Newport

    Orange, California, 92868, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Winship Cancer Institute / Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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