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NCT02942355 · ClinicalTrials.gov registry record · Phase 2
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
A Phase 2 study of Breast Cancer and Female Breast Carcinoma, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02942355: Active Phase 2 study of Breast Cancer and Female Breast Carcinoma, sponsored by Wake Forest University Health Sciences.
NCT02942355 is a Phase 2 study of Breast Cancer and Female Breast Carcinoma that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 40 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02942355, a Phase 2 study of Breast Cancer and Female Breast Carcinoma, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.
Primary Outcome
Determined for each subject as a binary variable indicating whether or not the participant experienced any neutropenic adverse event (according to NCI Common Terminology for Adverse Events version 4.0) that leads to permanent treatment discontinuation
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG anastrozole
Study Locations (1)
North Carolina
- Levine Cancer Institute - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT02942355 still lists
NCT02942355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib is the first listed.
NCT02942355 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02942355 about?
NCT02942355 is a clinical study titled "Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer". This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HE...
What is the current status of trial NCT02942355?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2016-12-07. Estimated completion is 2026-06-30.
What conditions does trial NCT02942355 study?
This clinical trial studies the following conditions: Breast Cancer, Female Breast Carcinoma.
What interventions are being tested in trial NCT02942355?
The interventions under investigation include: Palbociclib (DRUG), anastrozole (DRUG).
Who is sponsoring clinical trial NCT02942355?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02942355 being conducted?
This trial has 1 study location across North Carolina. 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 NCT02942355's enrollment target sits among peer trials
40 876th of 1224 higher than 325 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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