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

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorPfizer
Started

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Record History

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  1. Trial sites reduced: 167 → 157 locations
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Enrollment closed, study ongoing
    • Final enrollment: 74 participants (planned 100)
    • Study sites: 166 to 167
    v13
  3. Site details revised at 1 of 166 sitesv12
  4. Trial sites expanded: 159 → 166 locationsv11
  5. Study sites revised (159)v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 107 to 159
    • Eligibility criteria revised
    v9
  2. Study sites: 97 to 107v8
  3. Site details revised at 3 of 97 sitesv7
  4. Study sites: 19 to 97v6
  5. Study sites: 6 to 19v5
  6. 2 versions Re-verified since Jul 28, 2025, no change to tracked fieldsv3-v4
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 6
    • Primary completion date: Apr 29, 2027 to Oct 25, 2027
    • Study completion date: Aug 29, 2029 to Jan 27, 2030
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (7)
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
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.
Trial Details
NCT Number NCT06966453
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Breast Cancer, Breast Neoplasms
Related terms Breast Neoplasms
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov