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NCT03709082 · ClinicalTrials.gov registry record · Phase 1
Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
A Phase 1 study, sponsored by University of Kansas Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03709082: Clinical Trial Phase 1 study, sponsored by University of Kansas Medical Center.
NCT03709082 is a Phase 1 study that was terminated before completion, run by University of Kansas Medical Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03709082, a Phase 1 study, was terminated before completion, sponsored by University of Kansas Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1). Additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer. The study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase II dose (RP2D) of palbociclib in this combination and an expanded phase II of palbociclib at the RP2D in combination with letrozole and Ado- trastuzumab Emtansine (T-DM1). The starting dose of palbociclib will be 75 milligrams (mg) by mouth (PO) daily for each 21 day cycle. If 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity (DLT), the next 3 patients will be enrolled at the next higher dosing cohort of 100mg PO daily for each 21 day cycle. If 0 of 3 patients at the 100mg dose level experience a DLT, the next 3 patients will be enrolled at the next higher dosing cohort of 125mg PO daily for each 21 day cycle. If 0 of 3 patients at the 125mg dose level experience a DLT, 125mg PO daily of palbociclib will be the phase II recommended dose used in the phase II expanded cohort. Patients receiving the phase II recommended dose in phase I will be enrolled in phase II of the study. During safety lead-in and expanded phase II, Letrozole 2.5mg PO will be administered daily for each 21 day cycle and T-DM1 3.6 milligrams per kilograms intravenously (IV) will be administered on Day 1 of each 21 day cycle.
Primary Outcome
Determine overall response rate (ORR), defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Interventions
- DRUG T-DM1
- DRUG Letrozole 2.5mg
- DRUG Palbociclib 125mg
- DRUG Palbociclib 75mg
- DRUG Palbociclib 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2021-02-03 |
| Phase | Phase 1 |
Why NCT03709082 stopped before completion
NCT03709082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which T-DM1 is the first listed.
NCT03709082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03709082 about?
NCT03709082 is a clinical study titled "Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer". This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1). Additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer. The study will i...
What is the current status of trial NCT03709082?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2018-10-15. Estimated completion is 2021-02-03.
What interventions are being tested in trial NCT03709082?
The interventions under investigation include: T-DM1 (DRUG), Letrozole 2.5mg (DRUG), Palbociclib 125mg (DRUG), Palbociclib 75mg (DRUG), Palbociclib 100mg (DRUG).
Who is sponsoring clinical trial NCT03709082?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03709082's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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