Dysautonomia International

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

Purpose

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

Breast Cancer
Breast Neoplasms

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1: HER2+ locally advanced or metastatic breast cancer	disitamab vedotin monotherapy	Drug: Disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other names: RC48 RC48-ADC
Experimental Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer	disitamab vedotin monotherapy	Drug: Disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other names: RC48 RC48-ADC
Experimental Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer	disitamab vedotin monotherapy	Drug: Disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other names: RC48 RC48-ADC

Recruiting Locations

Southern Cancer Center, PC
Daphne, Alabama 36526

Southern Cancer Center, PC
Foley, Alabama 36535

Southern Cancer Center, PC
Mobile, Alabama 36608

Los Angeles Cancer Network - Anaheim
Anaheim, California 92805

Los Angeles Cancer Network
Fountain Valley, California 92708

Los Angeles Hematology Oncology Medical Group
Glendale, California 91204

Los Angeles Cancer Network
Los Angeles, California 90017

Valkyrie Clinical Trials
Los Angeles, California 90067

Mission Community Hospital (Satellite Site)
Los Angeles, California 91402

Clinical and Translational Research Unit (CTRU)
Palo Alto, California 94304

Stanford Cancer Center
Palo Alto, California 94304

Stanford Women's Cancer Center
Palo Alto, California 94304

Stanford Health Care, Investigational Drug Service
Stanford, California 94305

Los Angeles Hematology Oncology Medical Group
Van Nuys, California 91405

Rocky Mountain Cancer Centers, LLP
Aurora, Colorado 80012

Rocky Mountain Cancer Centers, LLP
Boulder, Colorado 80303

Rocky Mountain Cancer Centers, LLP
Centennial, Colorado 80112

Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado 80907

Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado 80923

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80220

Rocky Mountain Cancer Centers, LLP
Englewood, Colorado 80113

Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado 80228

Rocky Mountain Cancer Centers, LLP
Littleton, Colorado 80120

Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80124

Rocky Mountain Cancer Centers, LLP
Longmont, Colorado 80504

Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado 81003

Rocky Mountain Cancer Centers, LLP
Thornton, Colorado 80260

Smilow Cancer Hospital - Derby
Derby, Connecticut 06418

Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut 06824

Smilow Cancer Hospital - Glastonbury
Glastonbury, Connecticut 06033

Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut 06830

Smilow Cancer Hospital - Guilford
Guilford, Connecticut 06437

Smilow Cancer Hospital at St. Francis
Hartford, Connecticut 06105

Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut 06510

Yale-New Haven Hospital
New Haven, Connecticut 06510

Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut 06511

Yale School of Medicine
New Haven, Connecticut 06520

Smilow Cancer Hospital - North Haven
North Haven, Connecticut 06473

Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut 06902

Smilow Cancer Hospital - Torrington
Torrington, Connecticut 06790

Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut 06611

Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut 06708

Smilow Cancer Hospital - Waterford
Waterford, Connecticut 06385

Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
Washington D.C., District of Columbia 20007

Georgetown University Medical Center
Washington D.C., District of Columbia 20007

Medstar Georgetown University Hospital
Washington D.C., District of Columbia 20007

Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta, Georgia 30308

Emory Clinic Investigational Drug Services
Atlanta, Georgia 30322

Emory University Hospital
Atlanta, Georgia 30322

Winship Cancer Institute
Atlanta, Georgia 30322

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

Oncology Associates of Oregon, P.C.
Corvallis, Oregon 97330

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

Oncology Associates of Oregon, P.C.
Springfield, Oregon 97477

Alliance Cancer Specialists, PC
Bensalem, Pennsylvania 19020

Alliance Cancer Specialists, PC
Doylestown, Pennsylvania 18901

Alliance Cancer Specialists, PC
Horsham, Pennsylvania 19044

Alliance Cancer Specialists, PC
Langhorne, Pennsylvania 19047

Alliance Cancer Specialists, PC
Media, Pennsylvania 19063

Alliance Cancer Specialists, PC
Sellersville, Pennsylvania 18960

Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania 19096

Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Texas Oncology-Northeast Texas
Allen, Texas 75013

Texas Oncology - DFW
Arlington, Texas 76012

Texas Oncology - DFW
Arlington, Texas 76014

Texas Oncology - DFW
Bedford, Texas 76022

Texas Oncology - DFW
Dallas, Texas 75203

Texas Oncology - DFW
Dallas, Texas 75230

Texas Oncology - DFW
Dallas, Texas 75231

Texas Oncology - DFW
Dallas, Texas 75237

Texas Oncology - DFW
Dallas, Texas 75246

Texas Oncology-Northeast Texas
Denison, Texas 75020

Texas Oncology-Northeast Texas
Denton, Texas 76201

Texas Oncology-Northeast Texas
Flower Mound, Texas 75028

Texas Oncology - DFW
Fort Worth, Texas 76104

Texas Oncology - DFW
Grapevine, Texas 76051

US Oncology Investigation Products Center(IPC)
Irving, Texas 75063

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

Texas Oncology-Northeast Texas
Lewisville, Texas 75056

Texas Oncology-Northeast Texas
Longview, Texas 75601

Texas Oncology-Northeast Texas
McKinney, Texas 75071

Texas Oncology-Northeast Texas
Palestine, Texas 75801

Texas Oncology-Northeast Texas
Paris, Texas 75460

Texas Oncology - DFW
Plano, Texas 75075

Texas Oncology - DFW
Plano, Texas 75093

Texas Oncology - San Antonio
San Antonio, Texas 78217

Texas Oncology - San Antonio
San Antonio, Texas 78240

Texas Oncology-Northeast Texas
Tyler, Texas 75702

Virginia Cancer Specialists, PC
Arlington, Virginia 22201

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

Virginia Oncology Associates
Chesapeake, Virginia 23320

Virginia Cancer Specialists, PC
Fairfax, Virginia 22031

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

Virginia Cancer Specialists, PC
Manassas, Virginia 20110

Virginia Oncology Associates
Newport News, Virginia 23606

Virginia Oncology Associates
Norfolk, Virginia 23502

Virginia Cancer Specialists, PC
Reston, Virginia 20190

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

Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia 24153

Virginia Oncology Associates
Virginia Beach, Virginia 23456

Virginia Oncology Associates
Williamsburg, Virginia 23188

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia 24382

Swedish Cancer Institute
Seattle, Washington 98104

Swedish Medical Center
Seattle, Washington 98122

Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico 00935

More Details

Status: Recruiting
Sponsor: Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.