New drug shows promise for Hard-to-Treat breast cancer

NCT ID NCT06966453

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests a drug called disitamab vedotin in 100 adults with advanced breast cancer that has spread and is hard to treat. Participants must have tumors with HER2 protein and have had prior treatment. They receive the drug into a vein every two weeks. Researchers will check if the drug is safe and helps shrink tumors.

What this could mean

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

Active substance: disitamab vedotin (a drug given into the vein every 2 weeks)
What this could lead to: If this trial succeeds, it could point toward a new treatment option for people with advanced HER2-positive breast cancer that is hard to treat.
What could go wrong: This is an early-phase study (Phase 1b/2) with only 100 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors in many patients.

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

74 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Jan 2030

An estimate. End dates often move.

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: * Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma. * Human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status appropriate for enrollment in cohort. * HER2 status determined by most recent local assessment based on American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) guidelines for assessment of HER2 in BC for interpretation of HER2 expression and amplification * HER2+: immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridization (ISH)+ * HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative * HER2-ultralow: IHC 0 with membrane staining (any staining of the membrane in \>0 and ≤10% of cancer cells) o HR+ disease is determined as either estrogen receptor (ER) and/or progesterone receptor (PgR) positive \[ER or PgR ≥1%\]) and HR negative disease is determined as both ER and PR negative \[ER and PgR \<1%\]) per ASCO/CAP guidelines in the advanced disease setting. If a patient has had multiple ER/PgR results for advanced disease, the most recent test result will be used to confirm eligibility. Prior therapy requirements for Cohort 1 (HER2+, HR+ or HR- participants): * Received prior trastuzumab, pertuzumab and a taxane if available as local first line standard of care therapy for advanced disease. * Prior tucatinib based therapy is allowed. * Must have progression on or after, or be intolerant to, T-DXd in any line advanced disease setting. * No more than 3 prior systemic cytotoxic therapy regimens (including antibody drug conjugates \[ADCs\]) for Locally Advanced (LA)/metastatic breast cancer (mBC). Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC. Prior therapy requirements for Cohort 2 (HR+/HER2-low participants): * No more than 3 prior systemic cytotoxic therapy regimens (including ADCs) for LA/mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC. * Participants with known germline breast cancer gene (BRCA) mutation must have received a poly-ADP ribose polymerase (PARP) inhibitor, where available and not medically contraindicated. * Must have progression on or after, or be intolerant to, trastuzumab deruxtecan (T-DXd) in any line advanced disease setting. * Must have intolerance to endocrine therapy (ET) or ET refractory disease: * Progressed on ≥2 lines of ET for LA/mBC AND had received a cyclin-dependent kinase (CDK)4/6 inhibitor in the adjuvant or metastatic setting if available as local standard of care and not contraindicated. OR • Progressed on 1 line of ET for LA/mBC AND had a relapse while on adjuvant ET after definitive surgery for primary tumor AND had received a cyclin-dependent kinase (CDK) 4/6 inhibitor in the adjuvant or advanced setting if available as local standard of care and not contraindicated. Prior therapy requirements for Cohort 3 (HR+/HER2-ultralow or HR-/HER2-low \[HER2 low TNBC\] participants): * No more than 4 prior systemic cytotoxic chemotherapy regimens (including ADCs) for advanced or mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC. * Known germline BRCA mutation must have received a PARP-inhibitor if available as local standard of care therapy and not medically contraindicated. * Prior sacituzumab govitecan is allowed. * Prior T-DXd is allowed. * Participants with HR negative (TNBC), HER2-low and programmed cell death receptor ligand 1 (PD-L1)-positive (combined positive score \[CPS\] ≥10) tumors must have received pembrolizumab (or other PD-L1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated. * Participants with HR+/HER2-ultra low tumors must have received at least 1 antihormonal therapy in any setting or be ineligible for ET. * Participants with HR+/HER2-ultra low tumors must have had prior therapy with a CDK4/6 inhibitor in the adjuvant or advanced setting. Exclusion Criteria: * Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin. * Active central nervous system (CNS) and/or leptomeningeal metastasis. * Participants with a history of other invasive malignancy within 3 years before the Cycle 1 Day 1 (C1D1) of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. * Prior therapy with ADCs with MMAE payload. * Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks, or 5 half-lives, whichever is shorter, prior to C1D1 of study intervention. Note: If the last immediate anticancer treatment contained an antibody-based agent(s), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) prior to receiving the study intervention treatment is required. * Participants must have recovered from all adverse events due to previous therapies.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast neoplasms

Contacts and locations

Locations

ANIMI - Unidade de Tratamento Oncologico

Lages, Santa Catarina, 88501001, Brazil
Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan
Alliance Cancer Specialists, PC

Bensalem, Pennsylvania, 19020, United States
Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901, United States
Alliance Cancer Specialists, PC

Horsham, Pennsylvania, 19044, United States
Alliance Cancer Specialists, PC

Langhorne, Pennsylvania, 19047, United States
Alliance Cancer Specialists, PC

Media, Pennsylvania, 19063, United States
Alliance Cancer Specialists, PC

Sellersville, Pennsylvania, 18960, United States
Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania, 19096, United States
Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

Livorno, Tuscany, 57124, Italy
Banner Gateway Medical Center

Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Blacktown Hospital

Blacktown, New South Wales, 2148, Australia
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, 09541-270, Brazil
Charité University Hospital Berlin

Berlin, 10117, Germany
City of Hope National Medical Center

Duarte, California, 91010, United States
City of Hope at Irvine Lennar

Irvine, California, 92618, United States
Clinical and Translational Research Unit (CTRU)

Palo Alto, California, 94304, United States
Cro-Irccs

Aviano, Pordenone, 33081, Italy
Emory Clinic Investigational Drug Services

Atlanta, Georgia, 30322, United States
Emory University Hospital

Atlanta, Georgia, 30322, 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, 33701, United States
Florida Cancer Specialists

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

Tallahassee, Florida, 32308, 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy

Washington D.C., District of Columbia, 20007, United States
Hospital Beata María Ana

Madrid, 28007, Spain
Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain
Hospital Universitario Virgen Nieves

Granada, 18012, Spain
Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, 80131, Italy
Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

Essen, North Rhine-Westphalia, 45136, Germany
Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada
Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Mission Community Hospital (Satellite Site)

Los Angeles, California, 91402, United States
National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care

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

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

Wytheville, Virginia, 24382, United States
Oncology Associates of Oregon, P.C.

Albany, Oregon, 97321, United States
Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States
Oncology Associates of Oregon, P.C.

Springfield, Oregon, 97477, United States
Oncura Health - Anaheim

Anaheim, California, 92805, United States
Oncura Health - Corporate

Glendale, California, 91204, United States
Oncura Health - Fountain Valley

Fountain Valley, California, 92708, United States
Oncura Health - Good Samaritan

Los Angeles, California, 90017, United States
Oncura Health -Valley Presbyterian

Van Nuys, California, 91405, United States
Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico
Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [barcelona], 08003, Spain
Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers, LLP

Centennial, Colorado, 80112, United States
Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, 80923, United States
Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers, LLP

Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers, LLP

Longmont, Colorado, 80504, United States
Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, 81003, United States
Rocky Mountain Cancer Centers, LLP

Thornton, Colorado, 80260, United States
Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia
SCRI Oncology Partners

Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, 37203, United States
Smilow Cancer Hospital - Derby

Derby, Connecticut, 06418, United States
Smilow Cancer Hospital - Fairfield

Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital - Glastonbury

Glastonbury, Connecticut, 06033, United States
Smilow Cancer Hospital - Greenwich

Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital - Guilford

Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital - Long Ridge

Stamford, Connecticut, 06902, United States
Smilow Cancer Hospital - North Haven

North Haven, Connecticut, 06473, United States
Smilow Cancer Hospital - Torrington

Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital - Trumbull

Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital - Waterbury

Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital - Waterford

Waterford, Connecticut, 06385, United States
Smilow Cancer Hospital - Yale New Haven Health

New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital at St. Francis

Hartford, Connecticut, 06105, United States
Southern Cancer Center, PC

Daphne, Alabama, 36526, United States
Southern Cancer Center, PC

Foley, Alabama, 36535, United States
Southern Cancer Center, PC

Mobile, Alabama, 36608, United States
Stanford Cancer Center

Palo Alto, California, 94304, United States
Stanford Cancer Center Emeryville

Emeryville, California, 94608, United States
Stanford Cancer Center Pleasanton

Pleasanton, California, 94588, United States
Stanford Health Care, Investigational Drug Service

Stanford, California, 94305, United States
Stanford Healthcare - Portola Valley

Portola, California, 94208, United States
Stanford University Cancer Center South Bay

San Jose, California, 95124, United States
Stanford Women's Cancer Center

Palo Alto, California, 94304, United States
Swedish Cancer Institute

Seattle, Washington, 98104, United States
Swedish Medical Center

Seattle, Washington, 98122, United States
Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States
Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, 33065, United States
Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, 33021, United States
Sylvester Comprehensive Cancer Center - Kendall

Miami, Florida, 33176, United States
Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, 33324, United States
Sylvester Comprehensive Cancer Center - Sole Mia

North Miami, Florida, 33181, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States
Sylvester Comprehensive Cancer Center- Doral

Doral, Florida, 33166, United States
Texas Oncology - DFW

Arlington, Texas, 76012, United States
Texas Oncology - DFW

Arlington, Texas, 76014, United States
Texas Oncology - DFW

Bedford, Texas, 76022, United States
Texas Oncology - DFW

Dallas, Texas, 75203, United States
Texas Oncology - DFW

Dallas, Texas, 75230, United States
Texas Oncology - DFW

Dallas, Texas, 75231, United States
Texas Oncology - DFW

Dallas, Texas, 75237, United States
Texas Oncology - DFW

Dallas, Texas, 75246, United States
Texas Oncology - DFW

Fort Worth, Texas, 76104, United States
Texas Oncology - DFW

Grapevine, Texas, 76051, United States
Texas Oncology - DFW

Plano, Texas, 75075, United States
Texas Oncology - DFW

Plano, Texas, 75093, United States
Texas Oncology - San Antonio

San Antonio, Texas, 78217, United States
Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States
Texas Oncology-Northeast Texas

Allen, Texas, 75013, United States
Texas Oncology-Northeast Texas

Denison, Texas, 75020, United States
Texas Oncology-Northeast Texas

Denton, Texas, 76201, United States
Texas Oncology-Northeast Texas

Flower Mound, Texas, 75028, United States
Texas Oncology-Northeast Texas

Lewisville, Texas, 75056, United States
Texas Oncology-Northeast Texas

Longview, Texas, 75601, United States
Texas Oncology-Northeast Texas

McKinney, Texas, 75071, United States
Texas Oncology-Northeast Texas

Palestine, Texas, 75801, United States
Texas Oncology-Northeast Texas

Paris, Texas, 75460, United States
Texas Oncology-Northeast Texas

Tyler, Texas, 75702, United States
The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan
The University of Osaka Hospital

Suita, Osaka, 565-0871, Japan
US Oncology Investigation Products Center(IPC)

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

Irving, Texas, 75063, United States
University Hospital Carl Gustav Carus, Technical University Dresden

Dresden, Saxony, 01307, Germany
University of Miami Hospital and Clinics

Miami, Florida, 33136, United States
University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442, United States
Universitätsklinikum Leipzig

Leipzig, 04103, Germany
Valkyrie Clinical Trials

Los Angeles, California, 90067, United States
Virginia Cancer Specialists, PC

Arlington, Virginia, 22201, United States
Virginia Cancer Specialists, PC

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

Manassas, Virginia, 20110, United States
Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States
Virginia Oncology Associates

Chesapeake, Virginia, 23320, United States
Virginia Oncology Associates

Newport News, Virginia, 23606, United States
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
Virginia Oncology Associates

Virginia Beach, Virginia, 23456, United States
Virginia Oncology Associates

Williamsburg, Virginia, 23188, United States
Waterloo Regional Health Network

Kitchener, Ontario, N2G 1G3, Canada
Western Health-Sunshine & Footscray Hospitals

St Albans, Victoria, 3021, Australia
Winship Cancer Institute

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

Atlanta, Georgia, 30308, United States
Yale School of Medicine

New Haven, Connecticut, 06520, United States
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP

New Haven, Connecticut, 06511, United States
Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

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