A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
NCT ID: NCT06966453
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2025-06-30
2030-01-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: HER2+ locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Interventions
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Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Southern Cancer Center, PC
Daphne, Alabama, United States
Southern Cancer Center, PC
Foley, Alabama, United States
Southern Cancer Center, PC
Mobile, Alabama, United States
Los Angeles Cancer Network
Fountain Valley, California, United States
Los Angeles Cancer Network
Fountain Valley, California, United States
Los Angeles Hematology Oncology Medical Group
Glendale, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Mission Community Hospital (Satellite Site)
Los Angeles, California, United States
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Stanford Women's Cancer Center
Palo Alto, California, United States
Stanford Health Care, Investigational Drug Service
Stanford, California, United States
Los Angeles Hematology Oncology Medical Group
Van Nuys, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, United States
Florida Cancer Specialists
Clearwater, Florida, United States
Florida Cancer Specialists
Gainesville, Florida, United States
Florida Cancer Specialists
Largo, Florida, United States
Florida Cancer Specialists
Lecanto, Florida, United States
Florida Cancer Specialists
Ocala, Florida, United States
Florida Cancer Specialists
Orange City, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tallahassee, Florida, United States
Florida Cancer Specialists
Tampa, Florida, United States
Florida Cancer Specialists
Tavares, Florida, United States
Florida Cancer Specialists
The Villages, Florida, United States
Florida Cancer Specialists
Trinity, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Florida Cancer Specialists
Winter Park, Florida, United States
Oncology Associates of Oregon, P.C.
Albany, Oregon, United States
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
Oncology Associates of Oregon, P.C.
Springfield, Oregon, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, United States
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, United States
Alliance Cancer Specialists, PC
Media, Pennsylvania, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology-Northeast Texas
Allen, Texas, United States
Texas Oncology - DFW
Arlington, Texas, United States
Texas Oncology - DFW
Arlington, Texas, United States
Texas Oncology - DFW
Bedford, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Texas Oncology-Northeast Texas
Denison, Texas, United States
Texas Oncology-Northeast Texas
Denton, Texas, United States
Texas Oncology-Northeast Texas
Flower Mound, Texas, United States
Texas Oncology - DFW
Fort Worth, Texas, United States
Texas Oncology - DFW
Grapevine, Texas, United States
US Oncology Investigation Products Center(IPC)
Irving, Texas, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
Texas Oncology-Northeast Texas
Lewisville, Texas, United States
Texas Oncology-Northeast Texas
Longview, Texas, United States
Texas Oncology-Northeast Texas
McKinney, Texas, United States
Texas Oncology-Northeast Texas
Palestine, Texas, United States
Texas Oncology - Northeast Texas
Paris, Texas, United States
Texas Oncology-Northeast Texas
Paris, Texas, United States
Texas Oncology - DFW
Plano, Texas, United States
Texas Oncology - DFW
Plano, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Virginia Oncology Associates
Chesapeake, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States
Virginia Cancer Specialists, PC
Manassas, Virginia, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Specialists, PC
Reston, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Roanoke, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia, United States
Virginia Oncology Associates
Virginia Beach, Virginia, United States
Virginia Oncology Associates
Williamsburg, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Metro North Hospital and Health Service
Herston, Queensland, Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, Australia
Waterloo Regional Health Network
Kitchener, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Osaka University Hospital
Suita, Osaka, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2025-521003-52-00
Identifier Type: CTIS
Identifier Source: secondary_id
SGNDV-006
Identifier Type: OTHER
Identifier Source: secondary_id
C5731006
Identifier Type: -
Identifier Source: org_study_id
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