RecruitingRecruiting
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
NCT06966453 · Pfizer
In plain English
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Official title
A PHASE 1b/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER
About this study
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer).
This study is seeking participants who:
* have breast cancer that is hard to treat and has spread in the body (advanced cancer)
* have tumors that have HER2 on them
* have received previous treatment for their advanced breast cancer
All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein).
Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks.
The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.
Eligibility criteria
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.
Study design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-30
Estimated completion: 2030-01-27
Last updated: 2026-04-21
Interventions
Drug: Disitamab vedotin
Primary outcomes
- • Objective response (OR) by investigator assessment (From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (166)
Southern Cancer Center, PCRecruiting
Daphne, Alabama, United States
Southern Cancer Center, PCRecruiting
Foley, Alabama, United States
Southern Cancer Center, PCRecruiting
Mobile, Alabama, United States
Banner Gateway Medical CenterNot Yet Recruiting
Gilbert, Arizona, United States
Banner MD Anderson Cancer CenterNot Yet Recruiting
Gilbert, Arizona, United States
Los Angeles Cancer Network - AnaheimRecruiting
Anaheim, California, United States
City of Hope National Medical CenterNot Yet Recruiting
Duarte, California, United States
Los Angeles Cancer NetworkRecruiting
Fountain Valley, California, United States
Los Angeles Hematology Oncology Medical GroupRecruiting
Glendale, California, United States
City of Hope at Irvine LennarNot Yet Recruiting
Irvine, California, United States
Los Angeles Cancer NetworkRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Mission Community Hospital (Satellite Site)Recruiting
Los Angeles, California, United States
Clinical and Translational Research Unit (CTRU)Recruiting
Palo Alto, California, United States
Stanford Cancer CenterRecruiting
Palo Alto, California, United States
Stanford Women's Cancer CenterRecruiting
Palo Alto, California, United States
Stanford Health Care, Investigational Drug ServiceRecruiting
Stanford, California, United States
Los Angeles Hematology Oncology Medical GroupRecruiting
Van Nuys, California, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Centennial, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Englewood, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Littleton, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Longmont, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Thornton, Colorado, United States
Smilow Cancer Hospital - DerbyRecruiting
Derby, Connecticut, United States
Smilow Cancer Hospital - FairfieldRecruiting
Fairfield, Connecticut, United States
Smilow Cancer Hospital - GlastonburyRecruiting
Glastonbury, Connecticut, United States
Smilow Cancer Hospital - GreenwichRecruiting
Greenwich, Connecticut, United States
Smilow Cancer Hospital - GuilfordRecruiting
Guilford, Connecticut, United States
Smilow Cancer Hospital at St. FrancisRecruiting
Hartford, Connecticut, United States
Smilow Cancer Hospital - Yale New Haven HealthRecruiting
New Haven, Connecticut, United States
Yale-New Haven HospitalRecruiting
New Haven, Connecticut, United States
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOPRecruiting
New Haven, Connecticut, United States
Yale School of MedicineRecruiting
New Haven, Connecticut, United States
Smilow Cancer Hospital - North HavenRecruiting
North Haven, Connecticut, United States
Smilow Cancer Hospital - Long RidgeRecruiting
Stamford, Connecticut, United States
Smilow Cancer Hospital - TorringtonRecruiting
Torrington, Connecticut, United States
Smilow Cancer Hospital - TrumbullRecruiting
Trumbull, Connecticut, United States
Smilow Cancer Hospital - WaterburyRecruiting
Waterbury, Connecticut, United States
Smilow Cancer Hospital - WaterfordRecruiting
Waterford, Connecticut, United States
Georgetown University Medical Center - Department of Pharmacy, Oncology PharmacyRecruiting
Washington D.C., District of Columbia, United States
Georgetown University Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Medstar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
Florida Cancer SpecialistsNot Yet Recruiting
Clearwater, Florida, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical CenterNot Yet Recruiting
Coral Gables, Florida, United States
Sylvester Comprehensive Cancer Center - Coral SpringsNot Yet Recruiting
Coral Springs, Florida, United States
University of Miami Hospital and Clinics - Deerfield BeachNot Yet Recruiting
Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center- DoralNot Yet Recruiting
Doral, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center - HollywoodNot Yet Recruiting
Hollywood, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Largo, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Lecanto, Florida, United States
Sylvester Comprehensive Cancer CenterNot Yet Recruiting
Miami, Florida, United States
University of Miami Hospital and ClinicsNot Yet Recruiting
Miami, Florida, United States
Sylvester Comprehensive Cancer Center - KendallNot Yet Recruiting
Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Sole MiaNot Yet Recruiting
North Miami, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Ocala, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Orange City, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Orlando, Florida, United States
Sylvester Comprehensive Cancer Center - PlantationNot Yet Recruiting
Plantation, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
St. Petersburg, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Tallahassee, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Tampa, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Tavares, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
The Villages, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Trinity, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
West Palm Beach, Florida, United States
Florida Cancer SpecialistsNot Yet Recruiting
Winter Park, Florida, United States
Winship Cancer Institute @ Emory University Hospital MidtownRecruiting
Atlanta, Georgia, United States
Emory Clinic Investigational Drug ServicesRecruiting
Atlanta, Georgia, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Oncology Associates of Oregon, P.C.Recruiting
Albany, Oregon, United States
Oncology Associates of Oregon, P.C.Recruiting
Corvallis, Oregon, United States
Oncology Associates of Oregon, P.C.Recruiting
Eugene, Oregon, United States
Oncology Associates of Oregon, P.C.Recruiting
Springfield, Oregon, United States
Alliance Cancer Specialists, PCRecruiting
Bensalem, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Doylestown, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Horsham, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Langhorne, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Media, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Sellersville, Pennsylvania, United States
Alliance Cancer Specialists, PCRecruiting
Wynnewood, Pennsylvania, United States
Sarah Cannon Research Institute - PharmacyRecruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology-Northeast TexasRecruiting
Allen, Texas, United States
Texas Oncology - DFWRecruiting
Arlington, Texas, United States
Texas Oncology - DFWRecruiting
Arlington, Texas, United States
Texas Oncology - DFWRecruiting
Bedford, Texas, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Denison, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Denton, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Flower Mound, Texas, United States
Texas Oncology - DFWRecruiting
Fort Worth, Texas, United States
Texas Oncology - DFWRecruiting
Grapevine, Texas, United States
US Oncology Investigation Products Center(IPC)Recruiting
Irving, Texas, United States
US Oncology Investigational Product Center (IPC)Recruiting
Irving, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Lewisville, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Longview, Texas, United States
Texas Oncology-Northeast TexasRecruiting
McKinney, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Palestine, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Paris, Texas, United States
Texas Oncology - DFWRecruiting
Plano, Texas, United States
Texas Oncology - DFWRecruiting
Plano, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology-Northeast TexasRecruiting
Tyler, Texas, United States
Virginia Cancer Specialists, PCRecruiting
Arlington, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer CareRecruiting
Blacksburg, Virginia, United States
Virginia Oncology AssociatesRecruiting
Chesapeake, Virginia, United States
Virginia Cancer Specialists, PCRecruiting
Fairfax, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Low Moor, Virginia, United States
Virginia Cancer Specialists, PCRecruiting
Manassas, Virginia, United States
Virginia Oncology AssociatesRecruiting
Newport News, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Virginia Cancer Specialists, PCRecruiting
Reston, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer CareRecruiting
Roanoke, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer CareRecruiting
Salem, Virginia, United States
Virginia Oncology AssociatesRecruiting
Virginia Beach, Virginia, United States
Virginia Oncology AssociatesRecruiting
Williamsburg, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Wytheville, Virginia, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Blacktown HospitalRecruiting
Blacktown, New South Wales, Australia
Royal Brisbane and Women's HospitalRecruiting
Brisbane, Queensland, Australia
Western Health-Sunshine & Footscray HospitalsRecruiting
St Albans, Victoria, Australia
ANIMI - Unidade de Tratamento OncologicoRecruiting
Lages, Santa Catarina, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do SulRecruiting
São Caetano do Sul, São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Waterloo Regional Health NetworkRecruiting
Kitchener, Ontario, Canada
Lakeridge HealthRecruiting
Oshawa, Ontario, Canada
Kliniken Essen-Mitte, Evangelische Huyssens-StiftungRecruiting
Essen, North Rhine-Westphalia, Germany
University Hospital Carl Gustav Carus, Technical University DresdenNot Yet Recruiting
Dresden, Saxony, Germany
Charité University Hospital BerlinRecruiting
Berlin, Germany
Universitätsklinikum HeidelbergNot Yet Recruiting
Heidelberg, Germany
Universitätsklinikum LeipzigNot Yet Recruiting
Leipzig, Germany
Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
Naples, Campania, Italy
Azienda Ospedaliero-Universitaria di Bologna IRCCSRecruiting
Bologna, Emilia-Romagna, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"Recruiting
Meldola, Emilia-Romagna, Italy
Cro-IrccsRecruiting
Aviano, Friuli Venezia Giulia, Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di LivornoRecruiting
Livorno, Tuscany, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Roma, Italy
Aichi Cancer CenterRecruiting
Nagoya, Aichi-ken, Japan
Kanagawa cancer centerRecruiting
Yokohama, Kanagawa, Japan
The University of Osaka HospitalRecruiting
Suita, Osaka, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCRRecruiting
Koto, Tokyo, Japan
Pan American Center for Oncology Trials, LLCRecruiting
Rio Piedras, Puerto Rico
Parc de Salut Mar - Hospital del MarRecruiting
Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [barcelona], Spain
Hospital Universitario La PazRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Málaga, Spain
Hospital Clinico de ValenciaRecruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen NievesRecruiting
Granada, Spain
Hospital Beata María AnaRecruiting
Madrid, Spain