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NCT05069038 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
A Phase 2 study of Breast Cancer, sponsored by University of Nebraska.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT05069038: Active Phase 2 study of Breast Cancer, sponsored by University of Nebraska.
NCT05069038 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 51 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05069038, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. In addition, not all patients tolerate chemotherapy well. Pre-operative endocrine therapy has emerged as an effective strategy to improve outcomes in patients with early-stage hormone receptor positive breast cancer. This study will assess the role of neo-adjuvant palbociclib (CDK 4/6 inhibitor) in combination with letrozole (aromatase inhibitor) +/-Goserelin (GnRH analogue) to improve overall response and surgical feasibility in post and pre-menopausal hormone receptor positive and Her-2 negative subjects with stage IIA-IIIC breast cancer.
Primary Outcome
To determine the overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer
Conditions Studied
Interventions
- DRUG Palbociclib 125mg
Study Locations (1)
Nebraska
- Unversity of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2032-09 |
| Phase | Phase 2 |
What the registry record for NCT05069038 still lists
NCT05069038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Palbociclib 125mg is the first listed.
NCT05069038 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05069038 about?
NCT05069038 is a clinical study titled "Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy". Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular sub...
What is the current status of trial NCT05069038?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2022-03-02. Estimated completion is 2032-09.
What conditions does trial NCT05069038 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05069038?
The interventions under investigation include: Palbociclib 125mg (DRUG).
Who is sponsoring clinical trial NCT05069038?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05069038 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05069038's enrollment target sits among peer trials
51 782nd of 1224 higher than 437 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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