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Breast CancerPhase 1/2NCT06966453

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

A Phase 1/2 study testing Disitamab vedotin in people with Breast Cancer and Breast Neoplasms, run by Pfizer at 145 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Breast Neoplasms
What is being tested?
Disitamab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
145 sitesin 9 countries
Study dates
30 Jun 2025to 27 Jan 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 27Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

145 sites in 9 countries.

145 sites in 9 countries

United States120 sites

  • Oncology Associates of Oregon, P.C.

    Albany, Oregon, 97321

  • Texas Oncology-Northeast Texas

    Allen, Texas, 75013

  • Oncura Health - Anaheim

    Anaheim, California, 92805

  • Texas Oncology - DFW

    Arlington, Texas, 76012

  • Texas Oncology - DFW

    Arlington, Texas, 76014

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22201

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Texas Oncology - DFW

    Bedford, Texas, 76022

  • Alliance Cancer Specialists, PC

    Bensalem, Pennsylvania, 19020

  • Rocky Mountain Cancer Centers, LLP

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers, LLP

    Centennial, Colorado, 80112

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Rocky Mountain Cancer Centers, LLP

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers, LLP

    Colorado Springs, Colorado, 80923

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • Sylvester Comprehensive Cancer Center - Coral Springs

    Coral Springs, Florida, 33065

  • 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

  • Southern Cancer Center, PC

    Daphne, Alabama, 36526

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Texas Oncology-Northeast Texas

    Denison, Texas, 75020

  • Texas Oncology-Northeast Texas

    Denton, Texas, 76201

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80220

  • Smilow Cancer Hospital - Derby

    Derby, Connecticut, 06418

  • Sylvester Comprehensive Cancer Center- Doral

    Doral, Florida, 33166

  • Alliance Cancer Specialists, PC

    Doylestown, Pennsylvania, 18901

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Rocky Mountain Cancer Centers, LLP

    Englewood, Colorado, 80113

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Smilow Cancer Hospital - Fairfield

    Fairfield, Connecticut, 06824

  • Texas Oncology-Northeast Texas

    Flower Mound, Texas, 75028

  • Southern Cancer Center, PC

    Foley, Alabama, 36535

  • Texas Oncology - DFW

    Fort Worth, Texas, 76104

  • Oncura Health - Fountain Valley

    Fountain Valley, California, 92708

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Banner Gateway Medical Center

    Gilbert, Arizona, 85234

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Smilow Cancer Hospital - Glastonbury

    Glastonbury, Connecticut, 06033

  • Oncura Health - Corporate

    Glendale, California, 91204

  • Texas Oncology - DFW

    Grapevine, Texas, 76051

  • Smilow Cancer Hospital - Greenwich

    Greenwich, Connecticut, 06830

  • Smilow Cancer Hospital - Guilford

    Guilford, Connecticut, 06437

  • Smilow Cancer Hospital at St. Francis

    Hartford, Connecticut, 06105

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida, 33021

  • Alliance Cancer Specialists, PC

    Horsham, Pennsylvania, 19044

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • US Oncology Investigation Products Center(IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

  • Rocky Mountain Cancer Centers, LLP

    Lakewood, Colorado, 80228

  • Alliance Cancer Specialists, PC

    Langhorne, Pennsylvania, 19047

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • Texas Oncology-Northeast Texas

    Lewisville, Texas, 75056

  • 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

  • Texas Oncology-Northeast Texas

    Longview, Texas, 75601

  • Oncura Health - Good Samaritan

    Los Angeles, California, 90017

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Mission Community Hospital (Satellite Site)

    Los Angeles, California, 91402

  • Virginia Cancer Specialists, PC

    Manassas, Virginia, 20110

  • Texas Oncology-Northeast Texas

    McKinney, Texas, 75071

  • Alliance Cancer Specialists, PC

    Media, Pennsylvania, 19063

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • 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

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Smilow Cancer Hospital - North Haven

    North Haven, Connecticut, 06473

  • Sylvester Comprehensive Cancer Center - Sole Mia

    North Miami, Florida, 33181

  • Florida Cancer Specialists

    Ocala, Florida, 34474

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Texas Oncology-Northeast Texas

    Palestine, Texas, 75801

  • 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

  • Texas Oncology-Northeast Texas

    Paris, Texas, 75460

  • Texas Oncology - DFW

    Plano, Texas, 75075

  • Texas Oncology - DFW

    Plano, Texas, 75093

  • Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida, 33324

  • Rocky Mountain Cancer Centers, LLP

    Pueblo, Colorado, 81003

  • Virginia Cancer Specialists, PC

    Reston, Virginia, 20190

  • Alliance Cancer Specialists, PC

    Sellersville, Pennsylvania, 18960

  • Oncology Associates of Oregon, P.C.

    Springfield, Oregon, 97477

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33701

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Smilow Cancer Hospital - Long Ridge

    Stamford, Connecticut, 06902

  • Stanford Health Care, Investigational Drug Service

    Stanford, California, 94305

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Florida Cancer Specialists

    The Villages, Florida, 32159

  • Rocky Mountain Cancer Centers, LLP

    Thornton, Colorado, 80260

  • Smilow Cancer Hospital - Torrington

    Torrington, Connecticut, 06790

  • Florida Cancer Specialists

    Trinity, Florida, 34655

  • Smilow Cancer Hospital - Trumbull

    Trumbull, Connecticut, 06611

  • Texas Oncology-Northeast Texas

    Tyler, Texas, 75702

  • Oncura Health -Valley Presbyterian

    Van Nuys, California, 91405

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy

    Washington D.C., District of Columbia, 20007

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Smilow Cancer Hospital - Waterbury

    Waterbury, Connecticut, 06708

  • Smilow Cancer Hospital - Waterford

    Waterford, Connecticut, 06385

  • Virginia Oncology Associates

    Williamsburg, Virginia, 23188

  • Florida Cancer Specialists

    Winter Park, Florida, 32789

  • Virginia Cancer Specialists, PC

    Woodbridge, Virginia, 22191

  • Alliance Cancer Specialists, PC

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Italy5 sites

  • Cro-Irccs

    Aviano, Pordenone, 33081

  • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

    Livorno, Tuscany, 57124

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, Campania, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

Other trials in Italy

Germany4 sites

  • Charité University Hospital Berlin

    Berlin, 10117

  • University Hospital Carl Gustav Carus, Technical University Dresden

    Dresden, Saxony, 01307

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

    Essen, North Rhine-Westphalia, 45136

  • Universitätsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

Japan4 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

Other trials in Japan

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

  • Hospital Beata María Ana

    Madrid, 28007

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Australia3 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Western Health-Sunshine & Footscray Hospitals

    St Albans, Victoria, 3021

Other trials in Australia

Brazil2 sites

  • ANIMI - Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501001

  • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

    São Caetano do Sul, São Paulo, 09541-270

Other trials in Brazil

Canada2 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Waterloo Regional Health Network

    Kitchener, Ontario, N2G 1G3

Other trials in Canada

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

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:

Read more
  • 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.

Being tested
Disitamab vedotin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disitamab vedotinDrug

    Also called RC48, RC48-ADC

    Given into the vein (IV; intravenous) every 2 weeks.

Study groups in NCT06966453
Study groupRoleWhat they receive
Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancerExperimentaldisitamab vedotin monotherapy
Receives: Drug: Disitamab vedotin
Cohort 1: HER2+ locally advanced or metastatic breast cancerExperimentaldisitamab vedotin monotherapy
Receives: Drug: Disitamab vedotin
Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancerExperimentaldisitamab vedotin monotherapy
Receives: Drug: Disitamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response (OR) by investigator assessment

    The primary endpoint OR by investigator assessment is defined as the proportion of participants with confirmed CR or PR as determined by investigator per RECIST Version 1.1.

    Measured: 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

Secondary outcomes (7)

  1. Duration of response (DOR) per RECIST v1.1 by investigator assessment

    DOR by investigator assessment is defined as the time from first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause, whichever comes first.

    Measured: From first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause; up to approximately 2 years

  2. Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment

    DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.

    Measured: 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

  3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment

    PFS by investigator assessment is defined as the time from C1D1 to the first documentation of disease progression as determined by investigator per RECIST version 1.1, or to death due to any cause, whichever comes first.

    Measured: 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

  4. Overall survival (OS)

    OS is defined as the time from C1D1 to date of death due to any cause.

    Measured: From Cycle 1 Day 1 until death due to any cause; up to approximately 3 years

  5. PK Parameter: Serum Concentrations of disitamab vedotin, total antibody, and unconjugated MMAE

    The Antibody-drug conjugate (TAb), and unconjugated Monomethyl auristatin E (MMAE) concentrations for disitamab vedotin summarized at each PK sampling time point.

    Measured: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years

  6. Incidence of anti-drug antibodies (ADA) against disitamab vedotin

    The percentage of participants with positive ADA will be summarized.

    Measured: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years

  7. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Type, incidence, severity, seriousness, and relatedness of AEs. Type, incidence, and severity of laboratory abnormalities and significant changes from baseline.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start30 Jun 2025
  3. Primary completion25 Oct 2027 (estimated)
  4. Study completion27 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966453
Sponsor's protocol ID
C5731006
Other IDs
2025-521003-52-00, 2025
Status last verified
Nov 2026
First submitted
9 May 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Disitamab vedotin in people with Breast Cancer and Breast Neoplasms, run by Pfizer at 145 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Italy, Germany, Japan, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response (OR) by investigator assessment (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06966453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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