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

NCT06966453 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-21

No results posted yet for this study

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).

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

Interventions

DRUG

Disitamab vedotin

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-10-25
Completion
2030-01-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Germany
  • Italy
  • Japan
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966453 on ClinicalTrials.gov