Actively Recruiting
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
Led by Pfizer · Updated on 2026-04-21
100
Participants Needed
166
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
- HER2 and hormone receptor status appropriate for enrollment in cohort.
- HER2 status determined by most recent local assessment following ASCO and CAP guidelines.
- 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 in >0 and ≤10% of cancer cells.
- Hormone receptor positive (HR+): estrogen receptor or progesterone receptor ≥1%.
- Hormone receptor negative (HR-): estrogen receptor and progesterone receptor <1%.
- Prior therapy requirements vary by cohort, including previous treatments with trastuzumab, pertuzumab, taxane, tucatinib, T-DXd, PARP inhibitors, CDK4/6 inhibitors, sacituzumab govitecan, pembrolizumab, and antihormonal therapies according to cohort specifications.
- No more than 3-4 prior systemic cytotoxic therapy regimens for advanced/metastatic breast cancer depending on cohort.
You will not qualify if you...
- Known hypersensitivity to any excipient in disitamab vedotin.
- Active central nervous system (CNS) and/or leptomeningeal metastasis.
- History of other invasive cancer within 3 years before starting study treatment or evidence of residual disease from previous malignancy.
- Prior therapy with antibody-drug conjugates (ADCs) with MMAE payload.
- Received systemic anticancer treatment or radiotherapy within 2 weeks or 5 half-lives (whichever is shorter) before starting study treatment.
- Not fully recovered from side effects of previous therapies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 166 locations
1
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
Actively Recruiting
2
Southern Cancer Center, PC
Foley, Alabama, United States, 36535
Actively Recruiting
3
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
Actively Recruiting
4
Banner Gateway Medical Center
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
5
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
6
Los Angeles Cancer Network - Anaheim
Anaheim, California, United States, 92805
Actively Recruiting
7
City of Hope National Medical Center
Duarte, California, United States, 91010
Not Yet Recruiting
8
Los Angeles Cancer Network
Fountain Valley, California, United States, 92708
Actively Recruiting
9
Los Angeles Hematology Oncology Medical Group
Glendale, California, United States, 91204
Actively Recruiting
10
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Not Yet Recruiting
11
Los Angeles Cancer Network
Los Angeles, California, United States, 90017
Actively Recruiting
12
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
13
Mission Community Hospital (Satellite Site)
Los Angeles, California, United States, 91402
Actively Recruiting
14
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States, 94304
Actively Recruiting
15
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
16
Stanford Women's Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
17
Stanford Health Care, Investigational Drug Service
Stanford, California, United States, 94305
Actively Recruiting
18
Los Angeles Hematology Oncology Medical Group
Van Nuys, California, United States, 91405
Actively Recruiting
19
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
Actively Recruiting
20
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, United States, 80303
Actively Recruiting
21
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, United States, 80112
Actively Recruiting
22
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
23
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States, 80923
Actively Recruiting
24
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80220
Actively Recruiting
25
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, United States, 80113
Actively Recruiting
26
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States, 80228
Actively Recruiting
27
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States, 80120
Actively Recruiting
28
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
29
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States, 80504
Actively Recruiting
30
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, United States, 81003
Actively Recruiting
31
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, United States, 80260
Actively Recruiting
32
Smilow Cancer Hospital - Derby
Derby, Connecticut, United States, 06418
Actively Recruiting
33
Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
34
Smilow Cancer Hospital - Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
35
Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
36
Smilow Cancer Hospital - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
37
Smilow Cancer Hospital at St. Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
38
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States, 06510
Actively Recruiting
39
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
40
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, United States, 06511
Actively Recruiting
41
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
42
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, United States, 06473
Actively Recruiting
43
Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
44
Smilow Cancer Hospital - Torrington
Torrington, Connecticut, United States, 06790
Actively Recruiting
45
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
46
Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut, United States, 06708
Actively Recruiting
47
Smilow Cancer Hospital - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
48
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
49
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
50
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
51
Florida Cancer Specialists
Clearwater, Florida, United States, 33761
Not Yet Recruiting
52
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, United States, 33146
Not Yet Recruiting
53
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, United States, 33065
Not Yet Recruiting
54
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Not Yet Recruiting
55
Sylvester Comprehensive Cancer Center- Doral
Doral, Florida, United States, 33166
Not Yet Recruiting
56
Florida Cancer Specialists
Gainesville, Florida, United States, 32605
Not Yet Recruiting
57
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, United States, 33021
Not Yet Recruiting
58
Florida Cancer Specialists
Largo, Florida, United States, 33770
Not Yet Recruiting
59
Florida Cancer Specialists
Lecanto, Florida, United States, 34461
Not Yet Recruiting
60
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Not Yet Recruiting
61
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Not Yet Recruiting
62
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, United States, 33176
Not Yet Recruiting
63
Sylvester Comprehensive Cancer Center - Sole Mia
North Miami, Florida, United States, 33181
Not Yet Recruiting
64
Florida Cancer Specialists
Ocala, Florida, United States, 34474
Not Yet Recruiting
65
Florida Cancer Specialists
Orange City, Florida, United States, 32763
Not Yet Recruiting
66
Florida Cancer Specialists
Orlando, Florida, United States, 32806
Not Yet Recruiting
67
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, United States, 33324
Not Yet Recruiting
68
Florida Cancer Specialists
St. Petersburg, Florida, United States, 33705
Not Yet Recruiting
69
Florida Cancer Specialists
Tallahassee, Florida, United States, 32308
Not Yet Recruiting
70
Florida Cancer Specialists
Tampa, Florida, United States, 33607
Not Yet Recruiting
71
Florida Cancer Specialists
Tavares, Florida, United States, 32778
Not Yet Recruiting
72
Florida Cancer Specialists
The Villages, Florida, United States, 32159
Not Yet Recruiting
73
Florida Cancer Specialists
Trinity, Florida, United States, 34655
Not Yet Recruiting
74
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
Not Yet Recruiting
75
Florida Cancer Specialists
Winter Park, Florida, United States, 32789
Not Yet Recruiting
76
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
77
Emory Clinic Investigational Drug Services
Atlanta, Georgia, United States, 30322
Actively Recruiting
78
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
79
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
80
Oncology Associates of Oregon, P.C.
Albany, Oregon, United States, 97321
Actively Recruiting
81
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, United States, 97330
Actively Recruiting
82
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
83
Oncology Associates of Oregon, P.C.
Springfield, Oregon, United States, 97477
Actively Recruiting
84
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, United States, 19020
Actively Recruiting
85
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
86
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States, 19044
Actively Recruiting
87
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, United States, 19047
Actively Recruiting
88
Alliance Cancer Specialists, PC
Media, Pennsylvania, United States, 19063
Actively Recruiting
89
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, United States, 18960
Actively Recruiting
90
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
91
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States, 37203
Actively Recruiting
92
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
93
Texas Oncology-Northeast Texas
Allen, Texas, United States, 75013
Actively Recruiting
94
Texas Oncology - DFW
Arlington, Texas, United States, 76012
Actively Recruiting
95
Texas Oncology - DFW
Arlington, Texas, United States, 76014
Actively Recruiting
96
Texas Oncology - DFW
Bedford, Texas, United States, 76022
Actively Recruiting
97
Texas Oncology - DFW
Dallas, Texas, United States, 75203
Actively Recruiting
98
Texas Oncology - DFW
Dallas, Texas, United States, 75230
Actively Recruiting
99
Texas Oncology - DFW
Dallas, Texas, United States, 75231
Actively Recruiting
100
Texas Oncology - DFW
Dallas, Texas, United States, 75237
Actively Recruiting
101
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
102
Texas Oncology-Northeast Texas
Denison, Texas, United States, 75020
Actively Recruiting
103
Texas Oncology-Northeast Texas
Denton, Texas, United States, 76201
Actively Recruiting
104
Texas Oncology-Northeast Texas
Flower Mound, Texas, United States, 75028
Actively Recruiting
105
Texas Oncology - DFW
Fort Worth, Texas, United States, 76104
Actively Recruiting
106
Texas Oncology - DFW
Grapevine, Texas, United States, 76051
Actively Recruiting
107
US Oncology Investigation Products Center(IPC)
Irving, Texas, United States, 75063
Actively Recruiting
108
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States, 75063
Actively Recruiting
109
Texas Oncology-Northeast Texas
Lewisville, Texas, United States, 75056
Actively Recruiting
110
Texas Oncology-Northeast Texas
Longview, Texas, United States, 75601
Actively Recruiting
111
Texas Oncology-Northeast Texas
McKinney, Texas, United States, 75071
Actively Recruiting
112
Texas Oncology-Northeast Texas
Palestine, Texas, United States, 75801
Actively Recruiting
113
Texas Oncology-Northeast Texas
Paris, Texas, United States, 75460
Actively Recruiting
114
Texas Oncology - DFW
Plano, Texas, United States, 75075
Actively Recruiting
115
Texas Oncology - DFW
Plano, Texas, United States, 75093
Actively Recruiting
116
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78217
Actively Recruiting
117
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
118
Texas Oncology-Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
119
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22201
Actively Recruiting
120
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Blacksburg, Virginia, United States, 24060
Actively Recruiting
121
Virginia Oncology Associates
Chesapeake, Virginia, United States, 23320
Actively Recruiting
122
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
123
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Actively Recruiting
124
Virginia Cancer Specialists, PC
Manassas, Virginia, United States, 20110
Actively Recruiting
125
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Actively Recruiting
126
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
127
Virginia Cancer Specialists, PC
Reston, Virginia, United States, 20190
Actively Recruiting
128
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
129
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Actively Recruiting
130
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
131
Virginia Oncology Associates
Williamsburg, Virginia, United States, 23188
Actively Recruiting
132
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
Actively Recruiting
133
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
134
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
135
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
136
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
137
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, Australia, 3021
Actively Recruiting
138
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, Brazil, 88501001
Actively Recruiting
139
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, Brazil, 09541-270
Actively Recruiting
140
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
141
Waterloo Regional Health Network
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
142
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
143
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
144
University Hospital Carl Gustav Carus, Technical University Dresden
Dresden, Saxony, Germany, 01307
Not Yet Recruiting
145
Charité University Hospital Berlin
Berlin, Germany, 10117
Actively Recruiting
146
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
147
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
148
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, Italy, 80131
Actively Recruiting
149
Azienda Ospedaliero-Universitaria di Bologna IRCCS
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
150
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
151
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy, 33081
Actively Recruiting
152
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno, Tuscany, Italy, 57124
Actively Recruiting
153
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
154
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
155
Kanagawa cancer center
Yokohama, Kanagawa, Japan, 2418515
Actively Recruiting
156
The University of Osaka Hospital
Suita, Osaka, Japan, 565-0871
Actively Recruiting
157
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
158
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
159
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
160
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], Spain, 08003
Actively Recruiting
161
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain, 08035
Actively Recruiting
162
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain, 28046
Actively Recruiting
163
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010
Actively Recruiting
164
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain, 46010
Actively Recruiting
165
Hospital Universitario Virgen Nieves
Granada, Spain, 18012
Actively Recruiting
166
Hospital Beata María Ana
Madrid, Spain, 28007
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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