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NCT03530696 · ClinicalTrials.gov registry record · Phase 2
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT03530696: Completed Phase 2 study, sponsored by University of Arizona.
NCT03530696 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03530696, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.
Primary Outcome
Progression Free Survival (PFS) is defined as the time from date of first treatment to the date of investigator-determined objective disease progression as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 or death from any cause. Per RECIST 1.1 for target lesions: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters;
Interventions
- DRUG T-DM1
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 2 |
What the finished NCT03530696 record still lists
NCT03530696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which T-DM1 is the first listed.
NCT03530696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03530696 about?
NCT03530696 is a clinical study titled "T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer". This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.
What is the current status of trial NCT03530696?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2018-12-06. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT03530696?
The interventions under investigation include: T-DM1 (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT03530696?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03530696's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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