What is disitamab vedotin studying for advanced breast cancer?

Disitamab vedotin is being studied for adults with advanced breast cancer that is hard to treat and has spread. The study aims to understand the safety and effects of this medicine. It is sponsored by Pfizer and focuses on patients whose tumors have HER2 expression and who have had prior treatments.

Who may be eligible for this advanced breast cancer clinical trial?

Adults 18 years or older with locally advanced or metastatic breast cancer expressing HER2 may be eligible. Participants must have had previous treatments for advanced breast cancer and no active brain metastases. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced breast cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06966453

A Phase 1b/2 Open-Label Multicohort 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

117 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of locally advanced, unresectable, or metastatic breast carcinoma confirmed by tissue examination.
HER2 and hormone receptor status matching the study cohort requirements.
HER2 status confirmed by recent local assessment following ASCO and CAP guidelines.
For Cohort 1: HER2+ with prior trastuzumab, pertuzumab, taxane, and progression or intolerance to T-DXd, with up to 3 prior systemic therapies for advanced disease.
For Cohort 2: HR+/HER2-low with up to 3 prior systemic therapies, prior PARP inhibitor if BRCA mutation present, progression or intolerance to T-DXd, and endocrine therapy refractory or intolerant.
For Cohort 3: HR+/HER2-ultralow or HR-/HER2-low with up to 4 prior systemic therapies, prior PARP inhibitor if BRCA mutation present, prior sacituzumab govitecan and T-DXd allowed, and specific prior treatments depending on hormone receptor status.

You will not qualify if you...

Known allergy to any components of disitamab vedotin.
Active central nervous system or leptomeningeal metastases.
History of other invasive cancers within 3 years or any remaining disease from previous cancers.
Prior treatment with antibody drug conjugates containing MMAE.
Recent systemic anticancer therapy or radiotherapy within specified timeframes before starting the study drug.
Not fully recovered from side effects of prior therapies.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years or until disease progression or discontinuation.

Participants receive disitamab vedotin given intravenously every 2 weeks as monotherapy for HER2 expressing advanced breast cancer.

IV treatment every 2 weeks

Follow-up

Duration - Up to approximately 1 year after treatment ends (up to 3 years total from treatment start).

Participants are monitored for survival and safety outcomes after treatment ends.

Visits as needed for survival and safety assessments

Trial Site Locations

Total: 166 locations

Southern Cancer Center, PC

Daphne, Alabama, United States, 36526

Actively Recruiting

Southern Cancer Center, PC

Foley, Alabama, United States, 36535

Actively Recruiting

Southern Cancer Center, PC

Mobile, Alabama, United States, 36608

Actively Recruiting

Banner Gateway Medical Center

Gilbert, Arizona, United States, 85234

Not Yet Recruiting

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Not Yet Recruiting

Los Angeles Cancer Network - Anaheim

Anaheim, California, United States, 92805

Actively Recruiting

City of Hope National Medical Center

Duarte, California, United States, 91010

Not Yet Recruiting

Los Angeles Cancer Network

Fountain Valley, California, United States, 92708

Actively Recruiting

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States, 91204

Actively Recruiting

City of Hope at Irvine Lennar

Irvine, California, United States, 92618

Not Yet Recruiting

Los Angeles Cancer Network

Los Angeles, California, United States, 90017

Actively Recruiting

Valkyrie Clinical Trials

Los Angeles, California, United States, 90067

Actively Recruiting

Mission Community Hospital (Satellite Site)

Los Angeles, California, United States, 91402

Actively Recruiting

Clinical and Translational Research Unit (CTRU)

Palo Alto, California, United States, 94304

Actively Recruiting

Stanford Cancer Center

Palo Alto, California, United States, 94304

Actively Recruiting

Stanford Women's Cancer Center

Palo Alto, California, United States, 94304

Actively Recruiting

Stanford Health Care, Investigational Drug Service

Stanford, California, United States, 94305

Actively Recruiting

Los Angeles Hematology Oncology Medical Group

Van Nuys, California, United States, 91405

Actively Recruiting