New drug combo shows promise for Tough-to-Treat breast cancer

NCT ID NCT04539938

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

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

Summary

This study tested a combination of two drugs, tucatinib and trastuzumab deruxtecan (T-DXd), in 70 people with advanced HER2-positive breast cancer that had spread or couldn't be removed by surgery. The goal was to see how well the drugs shrank tumors and what side effects occurred. Participants received both drugs together, and the study measured tumor response and how long the cancer stayed under control.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

70 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2025

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 * Have confirmed HER2+ breast cancer, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines, previously determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory. * History of prior treatment with a taxane and trastuzumab in the LA/M setting OR progressed within 6 months after neoadjuvant or adjuvant treatment, including a taxane and trastuzumab. * Have progression of unresectable LA/M breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy * Have measurable disease assessable by RECIST v1.1 * Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 * Have a life expectancy of at least 6 months, in the opinion of the investigator * CNS Inclusion - Based on medical history and screening contrast brain magnetic resonance imaging (MRI), participants with a history of brain metastases must have one of the following: * Untreated brain metastases not needing immediate local therapy. For participants with untreated central nervous system (CNS) lesions \>2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment * Previously treated brain metastases * Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator * Participants treated with CNS local therapy for newly identified or previously treated progressing lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met: * Time since whole brain radiation therapy (WBRT) is ≥14 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥7 days prior to first dose of study treatment, or time since surgical resection is ≥28 days * Other sites of measurable disease by RECIST v1.1 are present * Relevant records of any CNS treatment must be available Exclusion Criteria * Have previously been treated with: * Lapatinib or neratinib within 12 months of starting study treatment (except in cases where lapatinib or neratinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity) * Tucatinib or enrolled on a tucatinib clinical trial * Any investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) (eg, afatinib) at any time previously * Trastuzumab deruxtecan or another antibody-drug conjugate (ADC) consisting of an exatecan derivative * Have received treatment with: * Any systemic anti-cancer therapy (including hormonal therapy) or experimental agent ≤21 days of first dose of study treatment or are currently participating in another interventional clinical trial. An exception for the washout of hormonal therapies is gonadotropin releasing hormone (GnRH) agonists used for ovarian suppression in premenopausal women, which are permitted concomitant medications * Treatment with non-CNS radiation ≤7 days prior to first dose of study treatment * Major surgery \<28 days of first dose of study treatment * Have clinically significant cardiopulmonary disease (such as history of iterstitial lung disease (ILD)/pneumonitis that required systemic corticosteroids, or have current ILD/pneumonitis, or where suspected ILD /pneumonitis cannot be ruled out be imaging at screening) * Have known myocardial infarction or unstable angina within 6 months prior to first dose of study treatment * Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks * Presence of known chronic liver disease * Active or uncontrolled clinically serious infection * Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications

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Conditions

The condition(s) this trial relates to.

breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast cancer

Contacts and locations

Locations

(IRB# 20-001502) Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, 90095, United States
Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Allina Health Cancer Institute

Saint Paul, Minnesota, 55102, United States
Allina Health Cancer institute

Minneapolis, Minnesota, 55407, United States
Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85711, United States
Atlanta Cancer Care - Atlanta

Atlanta, Georgia, 30342, United States
Atlanta Cancer Care - Cumming

Cumming, Georgia, 30041, United States
Atlanta Cancer Care - Stockbridge

Stockbridge, Georgia, 30281, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical center)

Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)

Duarte, California, 91010, United States
Dana Farber Cancer Institute- Chestnut Hill

Newton, Massachusetts, 02459, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC).

New York, New York, 10065, United States
Florida Cancer Specialists

Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists

Brandon, Florida, 33511, United States
Florida Cancer Specialists

Clearwater, Florida, 33761, United States
Florida Cancer Specialists

Gainesville, Florida, 32605, United States
Florida Cancer Specialists

Largo, Florida, 33770, United States
Florida Cancer Specialists

Lecanto, Florida, 34461, United States
Florida Cancer Specialists

Ocala, Florida, 34474, United States
Florida Cancer Specialists

Orange City, Florida, 32763, United States
Florida Cancer Specialists

Orlando, Florida, 32806, United States
Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists

Tampa, Florida, 33607, United States
Florida Cancer Specialists

Tavares, Florida, 32778, United States
Florida Cancer Specialists

The Villages, Florida, 32159, United States
Florida Cancer Specialists

Trinity, Florida, 34655, United States
Florida Cancer Specialists

Winter Park, Florida, 32789, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States
MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States
MSK Bergen

Montvale, New Jersey, 07645, United States
MSK Commack

Commack, New York, 11725, United States
MSK Monmouth

Middletown, New Jersey, 07748, United States
MSK Nassau

Uniondale, New York, 11553, United States
MSK Westchester

Harrison, New York, 10604, United States
Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital - Unity Campus

Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA

Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology, PA

Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, PA

Fridley, Minnesota, 55433, United States
Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology, PA

Saint Paul, Minnesota, 55102, United States
NHCI Suburban Hematology-oncology Associates - Duluth

Duluth, Georgia, 30096, United States
NHCI Suburban Hematology-oncology Associates - lawrenceville

Lawrenceville, Georgia, 30046, United States
Northside Hospital, Inc - GCS/Athens

Athens, Georgia, 30606, United States
Northside Hospital, Inc - GCS/Blairsville

Blairsville, Georgia, 30512, United States
Northside Hospital, Inc - GCS/Canton

Canton, Georgia, 30114, United States
Northside Hospital, Inc - GCS/Macon

Macon, Georgia, 31217, United States
Northside Hospital, Inc. - Central Research Department

Atlanta, Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Center Pointe

Atlanta, Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Decatur

Decatur, Georgia, 30033, United States
Northside Hospital, Inc. - GCS/Marietta

Marietta, Georgia, 30060, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

Low Moor, Virginia, 24457, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

Salem, Virginia, 24153, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68124, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists

Papillion, Nebraska, 68046, United States
Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Sarah Cannon Research Institute

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC

Cleveland, Tennessee, 37311, United States
Tennessee Oncology, PLLC

Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC

Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC

Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC

Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC

Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC

Lebanon, Tennessee, 37909, United States
Tennessee Oncology, PLLC

Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC

Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC

Smyrna, Tennessee, 37167, United States
The Emory Clinic

Atlanta, Georgia, 30322, United States
The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States
The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States
U.T. MD Anderson Cancer Center

Houston, Texas, 77030, United States
UC Health Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States
UCLA Hematology/Oncology

Los Angeles, California, 90095, United States
UCLA Hematology/Oncology - Alhambra

Alhambra, California, 91801, United States
UCLA Hematology/Oncology - Burbank

Burbank, California, 91505, United States
UCLA Hematology/Oncology - Laguna Hills

Laguna Hills, California, 92653, United States
UCLA Hematology/Oncology - Pasadena

Pasadena, California, 91105, United States
UCLA Hematology/Oncology - San Luis Obispo

San Luis Obispo, California, 93401, United States
UCLA Hematology/Oncology - Santa Barbara

Santa Barbara, California, 93105, United States
UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404, United States
UCLA Hematology/Oncology - Ventura

Ventura, California, 93003, United States
UCLA Hematology/Oncology - Westlake

Westlake Village, California, 91361, United States
UCLA Hematology/Oncology Parkside

Santa Monica, California, 90404, United States
UPMC Cancer Centers William M. Cooper Ambulatory Care Pavilion of the Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States
UPMC Hillman Cancer Center Mountainview

Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center Passavant North

Cranberry Township, Pennsylvania, 16066, United States
UPMC Hillman Cancer Center UPMC East

Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center Uniontown

Uniontown, Pennsylvania, 15401, United States
UPMC Hillman Cancer Center Upper Saint Clair

Pittsburgh, Pennsylvania, 15102, United States
UPMC Hillman Cancer Center Washington

Washington, Pennsylvania, 15301, United States
US Oncology Investigational Product Center (IPC)

Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States
US Oncology lnvestigational Products Center (IPC)

Irving, Texas, 75063, United States
UW Health Oncology - One South Park

Madison, Wisconsin, 53715, United States
United Hospital

Saint Paul, Minnesota, 55102, United States
University Of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University Of Alabama at Birmingham

Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, 35249, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States
University of Colorado Denver CTO/CTRC - Outpatient.

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, 80045, United States
University of Pittsburgh Cancer Institute Investigational Drug Service UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States
Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC

Gainesville, Virginia, 20155, United States
Virginia Cancer Specialists, PC

Leesburg, Virginia, 20176, United States
Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States
Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Winship Cancer Institute / Emory University School of Medicine

Atlanta, Georgia, 30322, United States
Winship Cancer Institute @ Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Zuckerberg San Francisco General Hospital- Breast Clinic

San Francisco, California, 94110, United States
Zuckerberg San Francisco General Hospital- Oncology Clinic

San Francisco, California, 94110, United States

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